BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 6017912 · Received October 11, 2016

    Report

    Report Number
    3015876-2016-01214
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 11, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K130454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).  PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE.  PHYSIO THEN REPLACED BOTH THE SYSTEM CONTROLLER (SC) AND USER INTERFACE (UI) PCB ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED SC PCB ASSEMBLY AND OBSERVED THAT SHORTED INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U61, WOULD NOT ALLOW THE DEVICE TO COMPLETE THE USER TEST; HOWEVER, NO DEVICE RESET OR LOCKUP ISSUES WERE OBSERVED.  IT WAS ALSO OBSERVED THAT THERAPY COULD BE DELIVERED. THE REMOVED UI PCB ASSEMBLY WAS AN ANCILLARY PART AND THERE WAS NO FAILURE OF THE ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. ADDITIONALLY, WHEN ATTEMPTING TO POWER THE DEVICE ON, THE DEVICE WOULD AUTOMATICALLY TRY TO PERFORM THE USER TEST. THE DEVICE WOULD THEN DISPLAY THAT THE TEST WAS UNSUCCESSFUL AND CYCLE POWER. THIS OCCURRED EACH TIME THE DEVICE WAS POWERED ON. AS A RESULT, DEFIBRILLATION COULD BE DELAYED OR PREVENTED IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669540 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1