BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 6132050 · Received November 29, 2016

    Report

    Report Number
    3015876-2016-01450
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    October 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS PERFORMED AN INITIAL EVALUATION OF THE DEVICE AND HAS BEEN ABLE TO DUPLICATE THE REPORTED ISSUE DURING TESTING.   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 FURTHER EVALUATED THE CUSTOMER'S DEVICE AND AFTER REPLACING THE CUSTOMER'S BATTERIES, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE LOST POWER DURING PATIENT CARE.  THE CUSTOMER INDICATED THAT THE DEVICE SHOWED BOTH OF THE BATTERY ICONS FLASHING AS IF THEY NEEDED A CHARGE, THEN THE DEVICE LOST POWER.  THERE WAS NO ADDITIONAL INFORMATION ON THE EVENT AVAILABLE NOR DID THE CUSTOMER HAVE ANY ADDITIONAL PATIENT DETAILS AVAILABLE.   THERE HAVE BEEN NO ADVERSE EFFECTS REPORTED TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781845 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1