BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2801030 · Received October 23, 2012

    Report

    Report Number
    3015876-2012-00786
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED ONLY A DC (BATTERY) POWER FAILURE. THE DEVICE OPERATED PROPERLY ON AC POWER. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. THE FOLLOW-UP MEDWATCH REPORT SHOULD READ: PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED ONLY A DC (BATTERY) POWER FAILURE. THE DEVICE OPERATED PROPERLY ON AC POWER. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED POWER SUPPLY ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE FAILURE TO BE DUE TO AN OPEN FE TRANSISTOR, DESIGNATOR Q10.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED ONLY A DC (BATTERY) POWER FAILURE. THE DEVICE OPERATED PROPERLY ON AC POWER. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE WAS RECENTLY REPAIRED AND RETURNED WITHOUT A BATTERY. WHEN A REPLACEMENT BATTERY WAS RECEIVED, THE DEVICE FUNCTIONED FOR A SHORT TIME AND THEN WOULD NOT POWER ON WITH AC OR DC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS REPORTED FAILURE.

    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