BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3945421 · Received July 21, 2014

    Report

    Report Number
    3015876-2014-00824
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    March 27, 2014
    Report Date
    June 24, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO THEN REPLACED THE THERAPY PCB ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO FURTHER EXAMINED THE REMOVED THERAPY PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS AN ELECTRICALLY LEAKY CAPACITOR, DESIGNATOR C160.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THERE WAS A SERVICE INDICATOR PRESENT ON THEIR DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EXAMINATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE UNIT HAD AN EVENT CODE IN THE MEMORY WHICH INDICATES THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE AND, AS A RESULT, THE UNIT MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426276 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1