BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR VUE WIRELESS FOOTSWITCH

    MDR report key: 10155074 · Received June 15, 2020

    Report

    Report Number
    1221934-2020-01550
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 28, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009657
    PMA / PMN Number
    K100638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> THE DEVICE WAS RECEIVED AT THE SERVICE CENTER. UPON ITS RETURN, UNIT WAS EVALUATED AND FOUND THAT IT WOULD NOT PAIR. THE FAILURE WAS DUE TO A CORRODED BATTERY TRAY ASSEMBLY. THE BATTERY TRAY ASSEMBLY WAS REPLACED AS IDENTIFIED IN THE INVESTIGATION TO ADDRESS THE ISSUE. THE REPAIR AND TESTING OF THE UNIT WAS COMPLETED PER THE SERVICE MANUAL, BRINGING THE UNIT BACK TO FULL FUNCTIONALITY. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. FLUID INGRESS INTO THE DEVICE WOULD HAVE CAUSED THE CORROSION OF THE BATTERY TRAY ASSEMBLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (SERIAL : (B)(6). LOT : 1201016), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (SERIAL : (B)(6). LOT : 1201016), AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REQUEST THAT A VAPR VUE WIRELESS FOOTSWITCH REUSABLE WAS RECEIVED. UNIT WAS EVALUATED AND WOULD NOT PAIR. THE FAILURE WAS DUE TO A CORRODED BATTERY TRAY ASSEMBLY THAT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616364 VAPR VUE WIRELESS FOOTSWITCH FOOT-SWITCH, ELECTRICAL GEI DEPUY MITEK LLC US 227214 10886705009657

    Patients

    Seq Age Sex Outcome Treatment
    1