BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER LIFEPAK 35 MONITOR DEFIBRILLATOR

    MDR report key: 21833802 · Received April 14, 2025

    Report

    Report Number
    MW5168979
    Event Type
    Injury
    Date Received
    April 14, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 8, 2025
    Manufacturer
    STRYKER/ PHYSIO-CONTROL MAASTRICHT, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STRYKER LIFEPAK 35 CARDIAC AND BLOOD PRESSURE MONITOR CONTINUES TO ERRONEOUSLY HIGH BLOOD PRESSURE ON CRITICALLY ILL AND INJURED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270311 STRYKER LIFEPAK 35 MONITOR DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ STRYKER/ PHYSIO-CONTROL MAASTRICHT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention