BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3023925 · Received March 27, 2013

    Report

    Report Number
    3015876-2013-00244
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL 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.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE MAGNET IN THE LID CAME LOOSE FROM ITS BONDED LOCATION AND STUCK TO THE DEVICE'S OUTER CASE. WITHOUT THE MAGNET IN ITS BONDED LOCATION ON THE LID, THE DEVICE WOULD NOT RECOGNIZE THE LID TO BE OPEN AND THE VOICE PROMPTS WOULD NOT START.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE DID NOT HAVE ANY VOICE PROMPTS. WITHOUT VOICE PROMPTS, THE DEVICE USER WOULD NOT BE ABLE TO FOLLOW THE DIRECTIONS GIVEN BY THE DEVICE, INCLUDING BUT NOT LIMITED TO CONNECTING THE DEFIBRILLATION ELECTRODES TO THE PATIENT, AND DELIVERING A SHOCK. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127217 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1