BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS FAN SPRAY KIT

    MDR report key: 2192749 · Received July 20, 2011

    Report

    Report Number
    1526350-2011-00149
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INJECTION ON THE ZIMMER PULSAVAC PLUS DEVICE SUDDENLY STOPPED DURING USE. AFTER THAT, THE UMBRELLA VALVE WAS FOUND TRAPPED IN THE JET ORIFICE. SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAVAC PLUS FAN SPRAY KIT PULSAVAC PLUS FAN SPRAY KIT FQH ZIMMER SURGICAL NA 61662089

    Patients

    Seq Age Sex Outcome Treatment
    1