Detector And Alarm, Arrhythmia
FDA adverse event reports and recall history for detector and alarm, arrhythmia (product code DSI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 33,339
- Deaths
- 505
- Injuries
- 2,606
- Malfunctions
- 30,165
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-01Open, ClassifiedProcess control
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
- 2026-04-07Open, ClassifiedComponent change control
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
- 2025-12-02Open, ClassifiedUse error
IntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-02Open, ClassifiedUse error
IntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-02Open, ClassifiedUse error
IntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-02Open, ClassifiedUse error
IntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-02Open, ClassifiedUse error
IntelliVue MP40. Product Number: M8003A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-02Open, ClassifiedUse error
IntelliVue MP50. Product Number: M8004A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-02Open, ClassifiedUse error
IntelliVue MP60. Product Number: M8005A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-02Open, ClassifiedUse error
IntelliVue MP70. Product Number: M8007A.
Potential issue where the IntelliVue monitors did not alarm.
Monitor detector and alarm, arrhythmia automatically
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