BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 6148975 · Received December 6, 2016

    Report

    Report Number
    1218950-2016-07711
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS FIELD SERVICE ENGINEER WENT ONSITE TO EVALUATE THE DEVICE. THE DEVICE PASSED ALL REQUIRED TESTING. FURTHER INFORMATION WAS PROVIDED TO PHILIPS STATING THE SALINE "GAUZE" WAS USED INSTEAD OF "CONDUCTIVE PASTE." THE INVOLVED DOCTOR BELIEVED THE HANDLE HAD ELECTRICAL LEAKAGE, HOWEVER A THOROUGH TESTING OF THE DEVICE DETERMINED THE HANDLE WORKED NORMALLY. AFTER THE FSE WORKED WITH THE DOCTOR AND CUSTOMER'S MEDICAL DEPARTMENT IT WAS AGREED UPON THE ISSUE WAS CAUSED BY THE MISUSE OF SALINE "GAUZE." : INFORMATION WAS SENT TO CUSTOMER REGARDING THEIR CONCERNS. THE INVESTIGATION DETERMINED THERE WAS NO DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT WHILE USING THE DEVICE ON A PATIENT THE DOCTOR WAS SHOCKED BY THE DEVICE. IT WAS REPORTED TO PHILIPS THE DOCTOR WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800165 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other