BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2882739 · Received December 20, 2012

    Report

    Report Number
    3015876-2012-00930
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 26, 2012
    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 DEVICE AND VERIFIED THE REPORTED FAILURE. 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 REPLACED THE FLEX CABLE ASSEMBLY WHICH CONNECTS THE USER INTERFACE PCB ASSEMBLY TO THE PCB STACK AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED FLEX CABLE ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO THE FLEX CABLE BEING BROKEN AT THE PLUG CONNECTOR, DESIGNATOR P21.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS NOT RETAINING THE CORRECT DATE AND TIME. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EXAMINATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE UNIT WOULD NOT COMPLETE THE BOOT-UP CYCLE AND THEREFORE, WOULD NOT BE ABLE TO PROVIDED DEFIBRILLATION THERAPY, IF NECESSARY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1