BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3910645 · Received July 2, 2014

    Report

    Report Number
    3015876-2014-00761
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. 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

    (B)(4): UPON FURTHER INVESTIGATION, PHYSIO-CONTROL DETERMINED THAT THE INFORMATION DOCUMENTED BY THE PHYSIO SERVICE REPRESENTATIVE WAS INCORRECT. THE ORIGINAL REPORTED ISSUE OF A CRITICAL EVENT CODE THAT MAY AFFECT THE DEVICE¿S ABILITY TO PROVIDE DEFIBRILLATION THERAPY IN AED MODE DID NOT OCCUR. PHYSIO OBSERVED NON-CRITICAL EVENT CODES IN THE MEMORY WHICH DID NOT AFFECT THE DEVICE¿S ABILITY TO PROVIDE DEFIBRILLATION THERAPY. PHYSIO-CONTROL ASSISTED THE BIOMEDICAL ENGINEER AT THE FACILITY WITH CLEARING THE NON-CRITICAL CODES FROM THE DEVICE¿S MEMORY AND CONDUCTING A PERFORMANCE INSPECTION PROCEDURE (PIP) WHICH PASSED. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. THERE WERE NO ASSEMBLIES REPLACED AS A RESULT OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT AND 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. UPON EXAMINATION OF THE DEVICE, PHYSIO OBSERVED THAT THE AED FUNCTION OF THE DEVICE WAS INOPERABLE AND, AS A RESULT, THE UNIT WOULD NOT HAVE BEEN ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE, IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388188 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1