BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3853817 · Received June 6, 2014

    Report

    Report Number
    3015876-2014-00627
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS ADVISED PHYSIO-CONTROL THAT THEY HAVE DECIDED TO NOT REPAIR THE DEVICE AT THIS TIME. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. THE CUSTOMER PROVIDED ADDITIONAL CLARIFICATION ON THE REPORTED EVENT. THE CUSTOMER INITIALLY REPORTED THAT THE REPORTED DEVICE FAILURE OCCURRED DURING A PATIENT EVENT; HOWEVER AFTER ADDITIONAL CLARIFICATION, THE REPORTED DEVICE FAILURE OCCURRED PRIOR TO A PATIENT EVENT. THIS DEVICE FAILURE OCCURRED, THE DEVICE WAS REMOVED FROM SERVICE, AND THEN THE PATIENT EVENT OCCURRED. THIS PATIENT EVENT REPORTED DID NOT INVOLVE A PHYSIO-CONTROL PRODUCT AND THERE WAS NO ADVERSE OUTCOME REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE WOULD NOT ENTER ADVISORY MODE. WITHOUT THE ADVISORY MODE, THE DEVICE COULD NOT BE USED BY (B)(6) WHO WOULD NEED THE AED MODE TO HAVE THE ABILITY TO DELIVER DEFIBRILLATION ENERGY TO A PATIENT. THERE WAS NO ADDITIONAL INFORMATION REGARDING THE PATIENT EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332707 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1