BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2991249 · Received March 6, 2013

    Report

    Report Number
    3015876-2013-00181
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL HAS ATTEMPTED TO CONTACT THE CUSTOMER MULTIPLE TIMES WITH NO RESOLUTION. IT IS UNKNOWN WHAT THE STATUS OF THE DEVICE IS OR IF THE DEVICE WILL BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION.THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMED, CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE TESTING THEIR DEVICE THEY OBSERVED THAT A SERVICE INDICATOR WAS PRESENT AND THAT THE UNIT WOULD NOT COMPLETE THE CHARGE CYCLE. AS A RESULT THE DEVICE WOULD NOT DEFIBRILLATE, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96086 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1