BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK® CR2 DEFIBRILLATOR

    MDR report key: 22283209 · Received June 18, 2025

    Report

    Report Number
    0003015876-2025-01240
    Event Type
    Death
    Date Received
    June 18, 2025
    Date of Event
    May 19, 2025
    Report Date
    July 14, 2025
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    P170018
    Adverse Event
    Yes
    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. A CLINICAL REVIEW WAS PERFORMED AND THE DEVICE CONTRIBUTION IS UNKNOWN DUE TO INSUFFICIENT INFORMATION. STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. STRYKER REQUESTS PATIENT INFORMATION NECESSARY FOR REGULATORY COMPLIANCE, STRICTLY ADHERING TO HIPAA'S PRIVACY RULE. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO STRYKER FOR EVALUATION. THE REPORTED ISSUE WAS DUPLICATED AND VERIFIED. REVIEW OF THE SOFTWARE LOGS INDICATED THE DEVICE WENT TO "REPLACE BATTERY" STATUS ON (B)(6) 2025 AND THEN TO "SHUTDOWN" STATUS ON (B)(6) 2025. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A MISSING MAGNET IN THE LID. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE AND THIS DEVICE WAS SCRAPPED BY STRYKER.

    Description of Event or Problem · 0

    A DISTRIBUTOR CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT POWER ON AND THAT THE MAGNET WAS MISSING IN THE DEVICE'S LID. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE PATIENT INVOLVED IS DECEASED.

    Description of Event or Problem · 0

    A DISTRIBUTOR CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT POWER ON AND THAT THE MAGNET WAS MISSING IN THE DEVICE'S LID. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE PATIENT INVOLVED IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767546 LIFEPAK® CR2 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CR2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death