BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 4173638 · Received October 15, 2014

    Report

    Report Number
    3015876-2014-01217
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 19, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL REPLACED THE POWER SUPPLY ASSEMBLY. THEREAFTER PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED POWER SUPPLY ASSEMBLY AND IT WAS OBSERVED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO PROCESS RESIDUE CONTAMINATION ON A FILTER, DESIGNATOR FL4, FROM THE POWER PCB ASSEMBLY. THE POWER PCB ASSEMBLY IS A COMPONENT LOCATED ON THE POWER SUPPLY ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE REQUIRED SERVICING. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THE DEVICE RESET ITSELF, OR LOCKED UP WHEN POWERED ON. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654901 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1