BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 6750348 · Received July 28, 2017

    Report

    Report Number
    3015876-2017-00923
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    October 25, 2016
    Report Date
    July 28, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT (PATIENT INFORMATION) WERE LEFT BLANK. THE INITIAL MEDWATCH REPORT (PATIENT INFORMATION) SHOULD INDICATE: (B)(6) YEARS OLD, MALE, (B)(6) KG.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED FROM THE DOWNLOADED KEY LOG THAT THE DEVICE HAD INDEED POWERED OFF AUTOMATICALLY. THE DEVICE WAS THEN EXTENSIVELY TESTED WITHOUT BEING ABLE TO REPRODUCE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD POWERED OFF AFTER DELIVERING THE FIRST DEFIBRILLATION SHOCK OF 200 JOULES TO A PATIENT. THE PARAMEDICS SWITCHED THE DEVICE BACK ON AND CONTINUED TO PROVIDE CPR TO THE PATIENT. IT WAS ALSO REPORTED THAT UPON RE-TESTING, THE CUSTOMER ASSUMED THAT THEY PRESSED THE ON/OFF BUTTON INSTEAD OF THE SHOCK BUTTON BUT FROM THE DOWNLOADED KEY LOG, PHYSIO OBSERVED THAT THE DEVICE HAD POWERED OFF AUTOMATICALLY.  NO INFORMATION ON THE PATIENT OUTCOME OR PATIENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532998 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1