BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 6861004 · Received September 13, 2017

    Report

    Report Number
    3015876-2017-01126
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    August 3, 2017
    Report Date
    January 25, 2018
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL. A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE BUT COULD NOT REPRODUCE THE REPORTED ISSUE. PHYSIO CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL. A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE BUT COULD NOT REPRODUCE THE REPORTED ISSUE. PHYSIO CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. UDI - (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVENTUALLY RETURNED TO PHYSIO-CONTROL. PHYSIO EVALUATED THE DEVICE AND OBSERVED THAT BATTERY 1 HAD A CROSS THREADED KEP NUT. FROM THE DOWNLOADED KEY LOG FILE IT WAS OBSERVED THAT THE DEVICE HAD POWERED OFF WHILE OPERATING ON BATTERY 1 AT T THE TIME OF THE REPORTED EVENT. PHYSIO REPLACED THE DEVICE'S REAR CASE (INCLUDING BATTERY WELLS AND KEP NUTS). PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER. THE LIKELY CAUSE OF THE REPORTED ISSUE WAS DUE TO A CROSS THREADED KEP NUT FOR BATTERY 1.

    Description of Event or Problem · 1

    A THIRD-PARTY SERVICE AGENT CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DEVICE FROM ONE OF THEIR CUSTOMERS HAD POWERED OFF BY ITSELF WHEN IT WAS USED ON A PATIENT. INFORMATION ON THE PATIENT DETAILS AND THE PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642723 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1