BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2884147 · Received December 21, 2012

    Report

    Report Number
    3015876-2012-00942
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL ADVISED THE CUSTOMER OF THE PART NUMBER FOR A REPLACEMENT THERAPY CONNECTOR ASSEMBLY. THE CUSTOMER HAS NOT ADVISED PHYSIO-CONTROL THE RESOLUTION OF THE DEVICE REPAIR. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    FOLLOW UP WITH THE REPORTER FOUND THAT THE CUSTOMER BIOMED RECEIVED THE THERAPY CONNECTOR ASSEMBLY. FURTHER FOLLOW UP ATTEMPTS TO CONFIRM IF THE THERAPY CONNECTOR REPLACEMENT RESOLVED THE REPORTED FAILURE WERE UNSUCCESSFUL. HOWEVER, THE DEVICE WAS RETURNED TO PHYSIO-CONTROL FOR UNRELATED REPAIRS A MONTH LATER AND PHYSIO FOUND NO EVIDENCE OF DEVICE FAILURE TO DETECT THE THERAPY CABLE CONNECTION. THE REPORTED DEVICE PROBLEM WAS LIKELY RESOLVED BY THE FACILITY BIOMED. PHYSIO COMPLETED THE OTHER UNRELATED REPAIRS AND CONFIRMED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER (BIOMED) REPORTED THAT THEIR DEVICE WAS INTERMITTENTLY GIVING A "CONNECT ELECTRODES" MESSAGE WHEN THEY HAD A DEFIBRILLATION THERAPY CABLE CONNECTED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE 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