BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER 2 BATTERY TENET 7609

    MDR report key: 10151630 · Received June 14, 2020

    Report

    Report Number
    1643264-2020-00370
    Event Type
    Malfunction
    Date Received
    June 14, 2020
    Date of Event
    January 1, 1901
    Report Date
    June 30, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GDC
    UDI-DI
    00885554023503
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3,H6: THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT FACILITY FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. NO PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION. H11: THE DATE OF THE EVENT (B3) OF THE INITIAL MDR SHOULD BE IN BLANK INSTEAD OF (B)(6) 1901 BECAUSE THE DATE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPIDER BATTERY HAD A BATTERY/CHARGER ISSUE AND THAT THE SPIDER HAD A LOSS OF TRACTION. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615267 SPIDER 2 BATTERY TENET 7609 TABLE, OPERATING-ROOM, ELECTRICAL GDC SMITH & NEPHEW, INC. UNKNOWN 00885554023503

    Patients

    Seq Age Sex Outcome Treatment
    1