BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3971752 · Received July 31, 2014

    Report

    Report Number
    3015876-2014-00880
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 7, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. AFTER MONITORING VOLTAGE LEVELS DURING TESTING, A SHORT WAS INDICATED INTERNALLY. 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

    AFTER ADDITIONAL EVALUATION OF THE DEVICE, PHYSIO-CONTROL REPLACED BOTH THE SYSTEM CONTROLLER AND USER INTERFACE PCBS, AND THE FLEX CABLE ASSEMBLY CONNECTING THE USER INTERFACE PCB TO THE PCB STACK AS A PRECAUTIONARY MEASURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS POWERING ITSELF ON AND WOULD NOT POWER OFF. AFTER AN ADDITIONAL EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE WOULD NO LONGER POWER ON AT ALL. THERE HAS BEEN NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448572 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1