BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK CR2 DEFIBRILLATOR

    MDR report key: 20737719 · Received November 20, 2024

    Report

    Report Number
    0003015876-2024-03207
    Event Type
    Death
    Date Received
    November 20, 2024
    Date of Event
    October 30, 2024
    Report Date
    January 17, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: STRYKER PRODUCT ASSESSMENT CENTER (PAC) TECHNICIAN VERIFIED BUT COULD NOT DUPLICATED THE REPORTED ISSUE OF FAILURE TO SENSE. THE DEVICE LOGS WERE ANALYZED AND IT WAS FOUND THAT THE DEVICE INTERMITTENTLY DETECTED A PATIENT LOAD BRIEFLY DURING THE PATIENT EVENT, BUT THE ISSUE COULD NOT BE REPRODUCED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. THE PAC TECHNICIAN CONFIRMED THE REPORTED ISSUE OF MISSING MAGNET. THE CAUSE OF THE REPORTED MISSING MAGNET WAS ISOLATED TO THE LID ASSEMBLY. THE DEVICE WAS ARCHIVED BY STRYKER AND THE CUSTOMER RECEIVED A REPLACEMENT. ADDITIONAL INFORMATION: STRYKER PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND DETERMINED THAT THE DEVICE USE MAY HAVE CONTRIBUTED TO THE PATIENT OUTCOME BECAUSE THE ECG WAS UNOBTAINABLE FOR ENTIRE USE OF DEVICE. CORRECTIONS: SECTION H6 MEDICAL DEVICE PROBLEM CODE OF THE INITIAL MEDWATCH REPORT INDICATES: CONNECTION PROBLEM DETACHMENT OF DEVICE OR DEVICE COMPONENT SECTION H6 MEDICAL DEVICE PROBLEM CODE OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: FAILURE TO SENSE DETACHMENT OF DEVICE OR DEVICE COMPONENT.

    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. 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.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT RECOGNIZING THE ELECTRODES. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE CUSTOMER ALSO REPORTED THEIR DEVICE WAS MISSING THE MAGNETIC PIN IN THE LID. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY, WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT RECOGNIZING THE ELECTRODES. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE CUSTOMER ALSO REPORTED THEIR DEVICE WAS MISSING THE MAGNETIC PIN IN THE LID. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY, WHICH CAN LEAD TO A USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459483 LIFEPAK CR2 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CR2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death