BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2981625 · Received February 27, 2013

    Report

    Report Number
    3015876-2013-00157
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT THERE WAS A SERVICE INDICATOR PRESENT AS WELL AS EVENT CODES IN THE MEMORY WHICH OCCURRED IN A RAPID FASHION DURING THE TIME OF THE PATIENT EVENT, WHICH IS INDICATIVE OF A DEVICE LOCKUP. HE THEN REPLACED BOTH THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A SHORTED DATA LINE (PIN 25) OF INTEGRATED CIRCUIT CHIP, DESIGNATOR U61 FROM THE SYSTEM CONTROLLER PCB ASSEMBLY. THE REMOVED USER INTERFACE PCB ASSEMBLY WAS FOUND TO HAVE BEEN FUNCTIONING NORMALLY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE DISPLAY WENT WHITE, WHICH IS INDICATIVE OF A DEVICE LOCKUP, AND WAS NON-RESPONSIVE. IT WAS ALSO OBSERVED THAT A SERVICE INDICATOR WAS PRESENT. A BACKUP DEVICE WAS READILY AVAILABLE AND WAS THEN USED TO CARE FOR THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83380 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1