BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® CR2 DEFIBRILLATOR

    MDR report key: 13022902 · Received December 16, 2021

    Report

    Report Number
    0003015876-2021-02376
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 30, 2021
    Report Date
    April 5, 2022
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873824139
    PMA / PMN Number
    P170018
    Removal / Correction Number
    3015876-01/14/2021-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO THE LID ASSEMBLY, BUT NEITHER THE LID NOR THE DEVICE WERE RETURNED TO STRYKER FOR EVALUATION, AND THEREFORE THE SPECIFIC ROOT CAUSE COULD NOT BE CONFIRMED. THE DEVICE MANUFACTURING RECORDS WERE EVALUATED AND IT WAS CONFIRMED THE LID WAS MANUFACTURED TO SPECIFICATION. THE DEVICE REMAINS IN SERVICE WITH THE CUSTOMER. AN ENGINEERING INVESTIGATION HAS DETERMINED THAT DUE TO THE DESIGN OF THE LPCR2 LID SWITCH, ABSENCE OF THE LID MAGNET ALLOWS CURRENT TO FLOW FROM THE BATTERY, EVEN WHEN THE DEVICE IS IN STANDBY MODE. THIS WILL REDUCE THE LIFE OF THE BATTERY. THEREFORE, THE REPORTED ISSUE, THE LOSS OF LID/LID MAGNET, IS ASSOCIATED WITH TWO HAZARDOUS SITUATIONS: OPENING THE LID DOES NOT TURN ON THE DEVICE, AND, HIGHER THAN INTENDED CURRENT DRAW WHILE THE DEVICE IS IN STANDBY MODE RESULTS IN A PREMATURELY DEPLETED THE BATTERY. REPLACEMENT OF THE DEVICE LID SO THAT THE MAGNET IS PRESENT IN THE DEVICE ALLOWS THE LID SWITCH TO FUNCTION AS DESIGNED; TURNING ON/OFF THE DEVICE WHEN THE LID IS OPENED AND PREVENTING CURRENT DRAW WHEN THE DEVICE LID IS CLOSED. THE LPCR2 OPERATING INSTRUCTIONS HAS BEEN UPDATED TO INCLUDE ADDITIONAL TROUBLESHOOTING TIPS TO DIRECT THE CUSTOMER TO ACT WHEN DEVICE BEHAVIOR INDICATES THE LID MAGNET MAY BE MISSING. A NEW WARNING INFORMS THE CUSTOMER OF THE RISK ASSOCIATED WITH A MISSING MAGNET. H3 OTHER TEXT : DEVICE NOT EVALUATED BY MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RECEIVED A REPLACEMENT DEVICE. 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 LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE¿S LID MAGNET WAS MISSING FROM THE LID. AS A RESULT, THE DEVICE MAY NOT AUTOMATICALLY POWER ON WHEN THE LID IS OPENED. THIS MAY LEAD TO DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920519 LIFEPAK® CR2 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CR2 00883873824139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown