BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 15 DEFIBRILLATOR/MONITOR

    MDR report key: 19582432 · Received June 21, 2024

    Report

    Report Number
    0003015876-2024-01959
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 30, 2024
    Report Date
    October 16, 2024
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Removal / Correction Number
    3015876-10/13/2023-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10 CONCOMITANT PRODUCTS GRID OF INITIAL MDR INDICATES: BLANK SECTION D10 CONCOMITANT PRODUCTS GRID OF INITIAL MDR SHOULD INDICATE: BASIC POWER SUPPLY, MKJ, 070097.

    Additional Manufacturer Narrative · 0

    THE AC POWER ADAPTER WAS NOT RETURNED TO STRYKER FOR EVALUATION. STRYKER DETERMINED THAT THE LIKELY CAUSE OF THE REPORTED ISSUE WAS DUE TO PROCESS ADHESIVE ON ONE OF THE DEVICE¿S AC INPUT PCBS. THIS CAN TRIGGER THE OVERVOLTAGE PROTECTION OF THE AC POWER ADAPTER AND MAY RESULT IN THE DEVICE BEING UNABLE TO POWER ON OR CHARGE THE BATTERIES.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S POWER SUPPLY FAILS, PREVENTING THE BATTERY FROM CHARGING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S POWER SUPPLY FAILS, PREVENTING THE BATTERY FROM CHARGING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S POWER SUPPLY FAILS, PREVENTING THE BATTERY FROM CHARGING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157521 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 070097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BASIC POWER SUPPLY, MKJ, 070097