BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) CR2 DEFIBRILLATOR

    MDR report key: 23693332 · Received December 2, 2025

    Report

    Report Number
    0003015876-2025-02517
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    October 16, 2025
    Report Date
    April 1, 2026
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    P170018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STRYKER CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR REPORT, WITH FDA REFERENCE 0003015876-2025-02517 AND STRYKER REFERENCE 4171094, SUBMITTED ON 12/02/2025, WAS SUBMITTED BASED ON THE INFORMATION AVAILABLE AT THE TIME. BASED ON ADDITIONAL INFORMATION OBTAINED DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE REPORTED ISSUE WAS DUE TO USER ERROR. THEREFORE, NO DEVICE MALFUNCTION OCCURRED NOR WAS THERE AN ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHOCKED AT 200 JOULES WHEN IN PEDIATRIC MODE. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO THE PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHOCKED AT 200 JOULES WHEN IN PEDIATRIC MODE. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO THE PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112713 LIFEPAK(R) CR2 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CR2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown