BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3649007 · Received February 27, 2014

    Report

    Report Number
    3015876-2014-00184
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 30, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER OF THE INITIAL MEDWATCH REPORT INDICATES: 3202459. CATALOG NUMBER OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: 3202488.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED INTERFACE PCB AND SYSTEM CONTROLLER PCB ASSEMBLIES. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN INTEGRATED CIRCUIT, DESIGNATOR U61 ON THE SYSTEM CONTROLLER PCB ASSEMBLY. THIS INTEGRATED CIRCUIT, DESIGNATOR U61 ON THE SYSTEM CONTROLLER PCB ASSEMBLY CAUSED THE DEVICE TO INTERMITTENTLY LOCK-UP AND THE SERVICE INDICATOR LED TO GO ON.

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: (B)(4) 2005. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: (B)(4) 2005.

    Additional Manufacturer Narrative · 1

    (B)(4). A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE THIRD-PARTY SERVICE AGENT REPLACED THE USER INTERFACE PCB AND SYSTEM CONTROLLER PCB ASSEMBLIES. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. AFTER REPAIR, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHYSIO-CONTROL THAT THE CUSTOMER'S DEVICE, DURING A ROUTINE PRE-SHIFT CHECK WOULD AUTOMATICALLY START A USER TEST WHENEVER IT WAS TURNED ON. AFTER COMPLETING THE USER TEST, THE DEVICE SWITCHED OFF. THE DEVICE'S OTHER FUNCTIONS WERE NOT AVAILABLE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122019 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1