BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAN SPRAY KIT

    MDR report key: 4482359 · Received January 30, 2015

    Report

    Report Number
    1526350-2015-00015
    Event Type
    Malfunction
    Date Received
    January 30, 2015
    Date of Event
    October 14, 2014
    Report Date
    January 27, 2015
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR PART NUMBER 00-5150-475-01, LOT 62695874. THIS DEVICE WAS MANUFACTURED AND PLACED INTO INVENTORY ON 06/19/2014. THERE WERE NO RELATED NON-CONFORMANCES. ENERGIZER "AA" BATTERIES PART NUMBER 06-0013-050-63 FROM LOT NUMBER 80615829 WERE USED IN THE ASSEMBLY OF THE REFERENCED PULSAVACS. THE SHELF LIFE FOR THE BATTERIES FOR THE LOT USED WAS THROUGH 12/2024. THE DEVICE WAS RETURNED IN A PLASTIC BAG. VISUALLY THE DEVICE DISPLAYED NO OBVIOUS DEFECTS AND THE BATTERY TERMINAL APPEARED TO BE UNHARMED. THE DEVICE DID NOT FUNCTION IN HIGH OR LOW SPEED MODE WHEN THE TRIGGER WAS MANIPULATED. AN INITIAL RESULT OF THE VOLTAGE MEASUREMENT OF THE BATTERY PACK WAS 0.0 VOLTS DUE TO DISCONTINUITY. SIX OF INDIVIDUAL BATTERIES DISPLAYED ALMOST A FULL CHARGE. TWO BATTERIES DISPLAYED CORROSION AND MEASURED A CHARGE OF 0.0 VOLTS. WHEN THE TWO BATTERIES WERE REPLACED AND THE BATTERY TERMINAL CONTACT WAS CLEANED THE DEVICE OPERATED NORMALLY IN BOTH LOW AND HIGH SPEED MODE. THE CUSTOMER'S REPORTED EVENT WAS CONFIRMED. THE CORROSION CAUSED A DISCONTINUITY IN THE POWER SUPPLY STREAM PREVENTING THE DEVICE FROM FUNCTIONING. A REVIEW OF THE ZIMMER SURGICAL MANUFACTURING, PACKING AND INSPECTION PROCESSES DENOTES NO SYSTEMIC ISSUES INDICATIVE TO THIS TYPE OF FAILURE. THE CAUSE FOR THE BATTERY DEGRADATION IS UNKNOWN. THE TRUE ROOT CAUSE FOR THE BATTERIES CORRODING IS UNKNOWN. THIS IS MOST LIKELY A FAILURE POSSIBLY DUE TO AN ENVIRONMENTAL AFFECT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER PULSAVAC PLUS DID NOT OPERATE FROM THE BEGINNING AND THE MOTOR DID NOT WORK. THE ISSUE OCCURRED DURING SURGERY, HOWEVER THERE WAS NO PATIENT INVOLVEMENT/INJURY ASSOCIATED WITH THE REPORT. THERE WAS NO DELAY TO THE PROCEDURE AS THE RESULT OF THE DEVICE ISSUE. DURING DEVICE EVALUATION IT WAS OBSERVED THAT THE RETURNED DEVICE HAD CORROSION ON THE BATTERIES AND THE CONTACT PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70201 FAN SPRAY KIT FAN SPRAY KIT GFD ZIMMER SURGICAL NA 62695874

    Patients

    Seq Age Sex Outcome Treatment
    1