BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART ADULT MULTIFUNCTION PADS PLUS

    MDR report key: 1637350 · Received March 12, 2010

    Report

    Report Number
    1218950-2010-00305
    Event Type
    Other
    Date Received
    March 12, 2010
    Report Date
    February 15, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K002806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO SHOCK DURING CARDIOVERSION. A SECOND SET OF PADS WERE USED WITH THE SAME RESULTS. NO ADVERSE PATIENT IMPACT WAS REPORTED. ON 2/22/2010, THE CUSTOMER REPORTED THIS ISSUE WAS NOT AN EQUIPMENT ISSUE BUT OPERATOR ERROR. THE OPERATOR OF THE DEFIBRILLATOR HAD TURNED THE ECG MAGNIFICATION DOWN TO 2.5MM WHICH RESULTED IN THE DEFIB NOT RECOGNIZING THE R WAVE TO CARDIOVERT. THEY ARE PROVIDING EXTRA TRAINING FOR THE STAFF WHO WERE INVOLVED. THERE WAS NOT A MALFUNCTION OF THE DEVICE, THE CUSTOMER CONFIRMED A USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO SHOCK DURING CARDIOVERSION. A SECOND SET OF PADS WERE USED WITH THE SAME RESULTS. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART ADULT MULTIFUNCTION PADS PLUS MKJ PHILIPS MEDICAL SYSTEMS M3713A

    Patients

    Seq Age Sex Outcome Treatment
    1