Urinometer, Electrical
FDA adverse event reports and recall history for urinometer, electrical (product code EXS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 463
- Deaths
- 0
- Injuries
- 3
- Malfunctions
- 460
Reports per year
Source: FDA adverse event reports by year received, 2017–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-12-14Open, ClassifiedUnder Investigation by firm
Sensica Urine Output System, Catalog Number SCCS1002
BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
- 2018-01-29TerminatedDevice Design
BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
- 2010-12-21TerminatedOther
Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container.
- TerminatedSoftware design
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
- Open, ClassifiedUnder Investigation by firm
Sensica Urine Output System
Complaints relating to urine output measurement accuracy.
- Open, ClassifiedOther
CritiCore Automated Urine Output and Temperature Monitor
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
Monitor urinometer, electrical automatically
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