BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2903844 · Received January 9, 2013

    Report

    Report Number
    3015876-2013-00024
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED POWER SUPPLY ASSEMBLY AND OBSERVED THAT AC POWER FAILED BUT DC POWER WAS STILL AVAILABLE WITH A CHARGED BATTERY. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A SHORTED FIELD EFFECT TRANSISTOR, DESIGNATOR Q6, WHICH CAUSED AN OPEN FUSE, DESIGNATOR F1.

    Description of Event or Problem · 1

    A PHYSIO-CONTROL SALES REPRESENTATIVE REPORTED THAT THEIR DEVICE WOULD NOT POWER ON WITH AC OR DC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11573 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1