BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR2 DEFIBRILLATOR

    MDR report key: 21431988 · Received February 21, 2025

    Report

    Report Number
    0003015876-2025-00328
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 21, 2025
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    P170018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STRYKER CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. DUE TO CHARACTER LIMITATIONS SECTION E1, INITIAL REPORTER PHONE, WAS LEFT BLANK. THE INITIAL REPORTER¿S PHONE NUMBER IS+011(081)05038218005

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT PROVIDE ANY VOICE PROMPTS WHEN THE DEVICE WAS POWERED ON. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666649 LIFEPAK CR2 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CR2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown