BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAN SPRAY KIT

    MDR report key: 5498217 · Received March 14, 2016

    Report

    Report Number
    0001526350-2016-00030
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    February 17, 2016
    Report Date
    March 15, 2016
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR PART NUMBER 00-5150-475-01, LOT 63095747. THIS DEVICE WAS MANUFACTURED AND PLACED INTO INVENTORY ON 7/21/2015. THERE WERE NO RELATED NON-CONFORMANCES, REQUEST FOR DEVIATION¿S (RFDS) OR OTHER ISSUES WITH THIS PRODUCTION LOT. (B)(4) ¿AA¿ BATTERIES PART NUMBER 06-0013-050-63 FROM LOT NUMBER 80684260 WERE USED IN THE ASSEMBLY OF THE REFERENCED PULSAVACS. THESE BATTERIES WERE CERTIFIED BY THE SUPPLIER AND PLACED INTO ZIMMER SURGICAL INVENTORY ON 5/19/2015. THE SHELF LIFE FOR THIS LOT IS THROUGH 12/2025. NO RELEVANT NON-CONFORMANCES WERE DISCOVERED FOR BATTERIES FROM THIS LOT IN INCOMING INSPECTION OR FROM THE ASSEMBLY/TEST AREA. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, INCOMING PRODUCT EVALUATION WAS NOT PERFORMED. THE DEVICE WAS DISPOSED OF BY THE CUSTOMER. THE CUSTOMER'S REPORTED EVENT WAS THAT WHEN PREPPING THE AREA FOR SURGERY THE PULSAVAC WHEN TESTED WOULD NOT FUNCTION. THE CUSTOMER REPORTED THAT A BATTERY HAD LEAKED. WITHOUT THE RETURNED DEVICE FOR EVALUATION THE REPORTED EVENT CANNOT BE CONFIRMED. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT DRAWINGS/SPECIFICATIONS AND THE PRODUCT MANUFACTURING/TESTING PROCESSES FOUND NO SPONTANEOUS OR SYSTEMIC ISSUES RELEVANT TO THIS REPORTED EVENT. WITH THE AVAILABLE INFORMATION, A SPECIFIC ROOT CAUSE CANNOT BE DETERMINED. THERE ARE TOO MANY VARIABLES TO SPECULATE A MOST LIKELY CAUSE FOR THIS REPORTED EVENT. NO RECOMMENDED ACTIONS AT THIS TIME; SEVERITY AND FREQUENCY DO NOT WARRANT FURTHER ACTIONS. ISSUE IS TRENDED BY QUALITY REPORTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE FAN SPRAY KIT DIDN'T FUNCTION DURING PREPARATION BEFORE SURGERY. THE BATTERY PACK WAS OPENED AND THE CUSTOMER FOUND THAT ONE OF THE BATTERIES HAD LEAKED. THERE WAS NO OPERATOR INJURY REPORTED AND NO MEDICAL INTERVENTION/ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED IN THE EVENT. AN ALTERNATE DEVICE WAS RETRIEVED FOR USE DURING THE SURGERY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155405 FAN SPRAY KIT PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN SPRAY KIT FQH ZIMMER SURGICAL, INC. N/A 63095747

    Patients

    Seq Age Sex Outcome Treatment
    1