BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ADULT MULTIFUNCTION PADS PLUS

    MDR report key: 3090271 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01435
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    April 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K002806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DEVICE FAILED TO DISCHARGE VIA PADS DURING A SYNCHRONIZED CARDIOVERSION. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169449 HEARTSTART ADULT MULTIFUNCTION PADS PLUS MKJ PHILIPS MEDICAL SYSTEMS M3713A 111312-01

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR