Welch Allyn Protocol, Inc.

Reports per year

Source: FDA adverse event reports by year received, 2001–2015. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Automated External Defibrillators (Non-Wearable)MKJ1,317
• Detector And Alarm, ArrhythmiaDSI704
• Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT70
• Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX59
• OximeterDQA22
• Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI11
• Monitor, St Segment With AlarmMLD7
• Connector, Airway (Extension)BZA5
• System, Measurement, Blood-Pressure, Non-InvasiveDXN5
• Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)DRO3

Recent recalls

• 2014-01-07TerminatedDevice Design

  The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

  Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.

• 2011-08-03TerminatedSoftware design

  Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Welch Allyn Protocol, Inc. Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors.

  Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.

• 2011-01-24TerminatedOther

  Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use in and out of the hospital.

  Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.

• 2010-11-12TerminatedOther

  ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001. The ViewSonic 19" flat panel LCD display Model VG930M is used as part of the Welch Allyn Acuity Central Monitoring System (Acuity System.) The Acuity System consists of a central monitoring station, Acuity System software, and a collection of other commercially available networked products

  The 19" Model VG930M ViewSonic flat panel LCD display may have faulty capacitors at certain locations in the power supply section. The faulty capacitors may cause a loss of power to the display resulting in the display screen going dark and loss of both visual and secondary patient alarms.

• 2009-07-30TerminatedDevice Design

  Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals.

  The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.

• 2009-07-06TerminatedLabeling design

  Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")

  Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to

• 2009-06-23TerminatedComponent design/selection

  Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")

  Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.

• 2009-03-10TerminatedDevice Design

  Welch Allyn AED 10 Automated External Defibrillator

  Potential for device to shut down prematurely under certain circumstances.

• 2009-03-10TerminatedProcess control

  Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")

  Potential for device to deliver less than the programmed energy.

• 2009-03-09TerminatedComponent design/selection

  Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")

  Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;