BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 3042019 · Received April 2, 2013

    Report

    Report Number
    1218950-2013-01174
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 27, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR WAS DELIVERING PACING SPIKES INAPPROPRIATELY. THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAD A "SUPERFICIAL BURN" WHERE THE DEFIBRILLATOR PADS HAD BEEN PLACED DURING PACING, WHICH WILL BE INVESTIGATED IN A SEPARATE COMPLAINT (REF MDR#1281950-2013-01175). THIS WAS ENTERED AS A SERIOUS INJURY, BUT IT IS NOT KNOWN FOR WHICH ISSUE THE CUSTOMER BELIEVES WAS A SERIOUS INJURY. WE ARE THEREFORE REPORTING BOTH ISSUES AS A SERIOUS INJURY. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR WAS DELIVERING PACING SPIKES INAPPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135290 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A NA

    Patients

    Seq Age Sex Outcome Treatment
    1