BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1964113 · Received December 21, 2010

    Report

    Report Number
    3015876-2010-01395
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON AC OR DC POWER. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY 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 POWER SUPPLY ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND OBSERVED NO AC OPERATION. THE CAUSE OF THE MALFUNCTION WAS DETERMINED TO BE A FAILURE OF THE AC POWER SUPPLY, TRANSISTORS Q1 AND Q2 WERE SHORTED AND FUSE F1 WAS OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON AC OR DC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA