BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    MDR report key: 3894259 · Received January 21, 2014

    Report

    Report Number
    1526350-2014-00041
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    November 4, 2013
    Report Date
    January 8, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE WAS NOT RETURNED TO THE MFR, THE CAUSE OF THE COMPLAINT WAS CONTRIBUTED TO THE PRESS FIT TIP LOCKING MECHANISM ON THE PULSAVAC PLUS. A DESIGN CHANGE HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPRAY CLIP CAME OFF OF THE PULSAVAC PLUS AND SPRAYED EVERYONE. ADD'L CLINICAL F/U WITH THE CUSTOMER INDICATED THAT THE TIP DETACHING FROM THE DEVICE DID NOT HAVE ANY HARM OR IMPACT TO THE PT OR PROCEDURE. THE LOCATION OF TIP DETACHMENT COULD NOT BE RECALLED BY THE CUSTOMER AND IT WAS CONFIRMED THAT THERE WAS NO MEDICAL INTERVENTION OR SURGICAL DELAY INVOLVED IN THE PROCEDURE. THE CUSTOMER STATED THAT THE SURGICAL TEAM WAS ALL EQUIPPED WITH PERSONAL PROTECTIVE EQUIPMENT (FACE SUITS); HOWEVER, THE ANESTHESIOLOGIST WAS WITHOUT PPE AND HAD DIRECT SKIN CONTACT WITH THE IRRIGATION FLUID SPRAY. IT WAS CONFIRMED THAT THERE WAS NO EMPLOYEE SEEKING A HEALTH F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50876 PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FQH ZIMMER SURGICAL NA 62468369

    Patients

    Seq Age Sex Outcome Treatment
    1