BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEST TUBE HEATER

    MDR report key: 20024462 · Received August 22, 2024

    Report

    Report Number
    9680654-2024-00067
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 6, 2024
    Report Date
    October 28, 2024
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQG
    PMA / PMN Number
    K983609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AFTER THREE UNSUCCESSFUL REQUESTS. THERE IS NO SERVICE HISTORY AVAILABLE FOR THIS DEVICE. THE K-FTH-1012 DEVICE IS A NON-REPAIRABLE DEVICE. REVIEW OF INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE FOUND IT TO CONTAIN SUFFICIENT INSTRUCTIONS AND GUIDANCE TO PRESERVE THE DEVICE AND ENSURE ITS PROPER FUNCTIONING, PROPER SERVICE, MAINTENANCE AND STORAGE MUST BE PROVIDED FOR INCLUDING: TO MAINTAIN THE DEVICE INTEGRITY AND FUNCTIONALITY, IT IS RECOMMENDED THAT THE DEVICE BE INSPECTED REGULARLY BY THE DEVICE OWNER OR USER FOR ANY SIGN OF WEAR OR DETERIORATION, E.G. IF THE CABLE SHEATH IS CRACKED OR BROKEN, OR DAMAGE FOR ONGOING OPERATIONAL SAFETY OF THE DEVICE, THE DEVICE MUST BE MAINTAINED AT REGULAR INTERVALS BY AN AUTHORISED SERVICE AGENT. THE SERVICE AGENT WILL VERIFY THE PERFORMANCE OF THE DEVICE. DEPENDING ON THE DURATION AND FREQUENCY OF USE, THE DEVICE SHOULD BE MAINTAINED AT LEAST ONCE A YEAR. REVIEW OF DEVICE HISTORY RECORD FOUND THE WORK ORDERS FOR THE COMPLAINT DEVICE APPEARED COMPLETE, AND THE QUALITY CONTROL INSPECTIONS WERE VERIFIED TO ENSURE THAT THE DEVICE PASSED INSPECTION. THERE WERE NO NON-CONFORMANCES RAISED OR TEMPORARY DEVIATIONS IN PLACE AT THE TIME OF MANUFACTURE. ALTHOUGH NO SERVICE REPORT WAS RECEIVED, BASED ON CONSULTATION WITH THE IN-HOUSE SUBJECT MATTER EXPERT (SME) ON THE MOST LIKELY CAUSE OF THE EVENT, FAILURE ¿WIRE DAMAGE", RESULTING FROM NORMAL WEAR AND TEAR WAS DETERMINED TO BE THE CAUSE. ACCORDING TO THE SME, THE EXPOSED VOLTAGE FROM THE POWER CORD IS 12V AND IS CONSIDERED TO BE LOW RISK TO THE USER. A REVIEW OF THE MANUFACTURING RECORDS AND SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THE INSTRUCTIONS FOR USE (IFU) ADVISES REGULAR INSPECTIONS FOR WEAR OR DAMAGE BY THE OWNER OR USER AND ANNUAL MAINTENANCE BY AN AUTHORISED SERVICE AGENT TO MAINTAIN OPERATIONAL SAFETY, AS OUTLINED IN THE DEVICE SERVICE MANUAL. SHOULD NEW INFORMATION BE RECEIVED, OR THE DEVICE RETURN BE AVAILABLE AT A LATER DATE, AN ADDITIONAL REPORT MAY BE SUPPLIED. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE.

    Additional Manufacturer Narrative · 0

    AWAITING DEVICE RETURN TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    THE WIRES OF THE POWER SUPPLY HAVE FRAYED. THIS GAVE A SCIENTIST 'A ZAP' WHILE USING THE DEVICE.

    Description of Event or Problem · 0

    THE WIRES OF THE POWER SUPPLY HAVE FRAYED. THIS GAVE A SCIENTIST A ZAP WHILE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118288 TEST TUBE HEATER MQG ACCESSORY, ASSISTED REPRODUCTION - COOK TEST TUBE HEATER MQG WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown