BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 4212166 · Received October 29, 2014

    Report

    Report Number
    3015876-2014-01287
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 3, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY BIOMEDICAL ENGINEER EXAMINED THE DEVICE AND WAS INITIALLY UNABLE TO DUPLICATE THE REPORTED ISSUE; HOWEVER, AT ONE POINT DURING THE TESTING WHEN TRYING TO ATTEMPT A 100 JOULE SHOCK, THE DEVICE WOULD CHARGE BUT NOT DEFIBRILLATE WHEN THE SHOCK BUTTON WAS PRESSED. THE DEVICE WAS THEN SENT TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT THUS FAR HAS BEEN UNABLE TO DUPLICATE OR VERIFY THE REPORTED ISSUE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    AFTER COMPLETING EXTENSIVE TESTING OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL HAS BEEN UNABLE TO DUPLICATE OR VERIFY THE REPORTED ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE DID NOT PROVIDE DEFIBRILLATION THERAPY WHEN PROMPTED. THE BIOMEDICAL ENGINEER WAS UNABLE TO PROVIDE THE DATE OF THE EVENT, ONLY THAT THE INCIDENT HAD OCCURRED THE WEEK PRIOR TO HIM CONTACTING PHYSIO-CONTROL TO REPORT IT. THE BIOMEDICAL ENGINEER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE, BUT WAS UNABLE TO ELABORATE FURTHER. A BACK UP DEVICE WAS AVAILABLE, BUT THE BIOMEDICAL ENGINEER DID NOT KNOW IF IT WAS USED TO PROVIDE DEFIBRILLATION THERAPY TO THE PATIENT. HE WAS ALSO UNABLE TO PROVIDE ANY PATIENT INFORMATION/DEMOGRAPHICS, OR ADDITIONAL DETAILS ABOUT THE EVENT DUE TO THEIR INTERNAL PRIVACY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692004 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1