BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3921108 · Received July 9, 2014

    Report

    Report Number
    3015876-2014-00779
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 11, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. 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 BUT COULD NOT DUPLICATE THE REPORTED FAILURE OF EXCESSIVE MOTION ALARMS. IT WAS OBSERVED THAT THE DEVICE WOULD CHARGE AND SHOCK DEFIBRILLATION ENERGY. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. AN INTERNAL INSPECTION OF THE DEVICE WAS PERFORMED WITHOUT OBSERVING ANY DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL SERVICE AGENT THAT THE CUSTOMER'S DEVICE CONTINUOUSLY GAVE THE PROMPT 'MOTION DETECTED'; ALSO WHEN THERE WAS NO MOTION. THEREFORE THE DEVICE WOULD NOT PROVIDE AN ANALYSIS OF A PATIENT'S HEART RHYTHM WHEN REQUIRED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400188 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1