BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS FAN SPRAY KIT

    MDR report key: 4173562 · Received August 7, 2014

    Report

    Report Number
    1526350-2014-00409
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED IN THE ORIGINAL ZIMMER CARTON, BUT IN A CLEAR PLASTIC BAG. UPON RECEIPT IT WAS NOTED THAT THE DEVICE WAS RECEIVED WITH THE TRIGGER LOCKED IN THE LOW MODE. THE DEVICE DID NOT OPERATE AT ALL. THE DEVICE WAS OPENED UP AND CORROSION ON THE TERMINAL AND ON ONE OF THE BATTERIES WAS DISCOVERED. ALL THE BATTERIES WERE COMPLETELY DEPLETED. SCRAPPING THE CORROSION OFF THE TERMINAL AND REPLACING ALL THE BATTERIES ALLOWED THE DEVICE TO OPERATE NORMALLY. NO NOISE ISSUE WAS OBSERVED; HOWEVER THE CUSTOMER'S REPORTED EVENT OF THE DEVICE NOT WORKING WAS CONFIRMED. THE ROOT CAUSE OF THE DEVICE NOT WORKING IS UNABLE TO BE DETERMINED. WHEN THE CORROSION OCCURRED ON THE BATTERY AND WHEN THE DEPLETION OF THE BATTERIES OCCURRED IS UNKNOWN. THE CONDITION OF THE ORIGINAL SHIPPING PACKAGE AT RECEIPT AND THE STORAGE ENVIRONMENT OF THE DEVICE, AT THE CUSTOMER AS WELL AS THE LENGTH OF TIME IN STORAGE ARE UNKNOWN. A REVIEW OF THE ZIMMER SURGICAL MANUFACTURING, PACKING AND INSPECTION PROCESSES DENOTES NO ISSUES INDICATIVE TO THIS TYPE OF FAILURE. THE CAUSE FOR THE BATTERY DEGRADATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER PULSAVAC PLUS HAD STOPPED WHILE IN USE. IN OPERATION, NOISE HAD OCCURRED. THE CUSTOMER USED AND FINISHED THE SURGERY WITH AN ALTERNATE ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463144 PULSAVAC PLUS FAN SPRAY KIT PULSAVAC PLUS FAN SPRAY KIT FQH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1