BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3223090 · Received July 12, 2013

    Report

    Report Number
    3015876-2013-00611
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 17, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO VERIFY THE REPORTED FAILURE. AS A PRECAUTION, PHYSIO REPLACED THE SYSTEM PCB ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED SYSTEM PCB ASSEMBLY BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE ASSEMBLY OPERATED AS INTENDED WHEN TESTED IN A MOCK-UP DEVICE, EVEN AT HOT OR COLD TEMPERATURES, OR VARIABLE HUMIDITY. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO VERIFY THE REPORTED FAILURE. AS A PRECAUTION, PHYSIO REPLACED THE SYSTEM PCB ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED SYSTEM PCB ASSEMBLY BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE ASSEMBLY OPERATED AS INTENDED WHEN TESTED IN A MOCK-UP DEVICE, EVEN AT HOT OR COLD TEMPERATURES, OR VARIABLE HUMIDITY. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO VERIFY THE REPORTED FAILURE. AS A PRECAUTION, PHYSIO REPLACED THE SYSTEM PCB ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED SYSTEM PCB ASSEMBLY BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE ASSEMBLY OPERATED AS INTENDED WHEN TESTED IN A MOCK-UP DEVICE, EVEN AT HOT OR COLD TEMPERATURES, OR VARIABLE HUMIDITY. UPON REVIEW OF THE ELECTRONIC PATIENT RECORD (.PCO FILE) FROM THE PATIENT EVENT, PHYSIO OBSERVED THAT THE DEVICE GAVE MULTIPLE "REPLACE BATTERY" PROMPTS AS SOON AS THE DEVICE WAS POWERED ON FOR USE. THE "REPLACE BATTERY" PROMPTS INDICATED THAT BOTH BATTERY 1 AND BATTERY 2 WERE DEPLETED AND REQUIRED REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE ATTEMPTING TO MONITOR A PATIENT THEIR DEVICE POWERED OFF ON ITS OWN. THE CUSTOMER CONFIRMED THAT THE DEVICE WAS USING TWO KNOWN WORKING BATTERIES THAT WERE FULL. NO FURTHER DETAILS WERE PROVIDED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323609 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1