BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEST TUBE HEATER

    MDR report key: 22354347 · Received June 30, 2025

    Report

    Report Number
    9680654-2025-00029
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Report Date
    November 19, 2025
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQG
    PMA / PMN Number
    K983609
    Removal / Correction Number
    SCAR2025-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THREE REQUESTS, NO FURTHER INFORMATION WAS RECEIVED REGARDING DEVICE ASSESSMENT/ REPLACEMENT. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE WORK ORDER FOR LOT AM111170 APPEARED COMPLETE, AND THE QUALITY CONTROL INSPECTION RECORD WAS VERIFIED TO ENSURE THAT THE DEVICE PASSED INSPECTION. THERE WERE NO NON-CONFORMANCES RAISED AT THE TIME OF MANUFACTURE. 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 AND CONFIRMED THAT THE FAILURE HAS NOT PREVIOUSLY OCCURRED FOR THIS MANUFACTURING LOT. THE POST-MARKET ENGINEERING TEAM/SUBJECT MATTER EXPERTS WERE CONSULTED TO ASSESS THE POTENTIAL OF HARM OF THE REPORTED ISSUE. IT WAS STATED "THE IMAGE SHOWS DAMAGE TO THE INSULATION OF THE WIRES ON THE OUTPUT SIDE OF THE K-APS-300 POWER SUPPLY. THE PURPOSE OF THE K-APS-300 POWER SUPPLY IS TO CONVERT MAINS VOLTAGES (100 ¿ 2340 VAC) TO 12VDC. THEREFORE, DAMAGE TO THE INSULATION PERMITS ACCESS TO 12V ONLY. IN ACCORDANCE WITH IEC 60950-1, VOLTAGES LESS THAN 60VDC ARE CLASSIFIED AS SAFETY EXTRA-LOW VOLTAGE (SELV) AS THEY ARE CONSIDERED SAFE FOR AN ORDINARY PERSON TO TOUCH. THEREFORE, REPORTS OF ¿ZAPS¿ FROM THE POWER SUPPLY (OR SIMILAR) MUST REFER TO SPARKING OR ARCING AS THE EXPOSED WIRES CONTACT EACH OTHER CAUSING A ¿SHORT CIRCUIT¿. THERE IS NO RISK OF ELECTRICAL SHOCK TO THE USER. THE K-APS-300 POWER SUPPLY CONTAINS OVER-VOLTAGE, OVER CURRENT AND SHORT CIRCUIT PROTECTION. IN ADDITION TO THIS, THE DESIGN OF THE POWER SUPPLY HAS BEEN VERIFIED TO MEET THE REQUIREMENTS OF IEC 60601-1:2012. THE STANDARD REQUIRES THAT THE POWER SUPPLY REMAINS SAFE TO USE UNDER NORMAL AND SINGLE-FAULT CONDITIONS. IT HAS ALSO BEEN TESTED TO VERIFY THAT THE ISOLATION BETWEEN THE MAINS INPUT AND THE 12V OUTPUT IS AT MINIMUM 4KV." BASED ON THE INFORMATION PROVIDED AND IN CONSULTATION WITH THE SUBJECT MATTER EXPERT, A NEW POTENTIAL FAILURE MODE WAS INTRODUCED TO ADDRESS THIS ISSUE: "WIRE INSULATION DAMAGED / WIRE CONDUCTORS EXPOSED / ¿FRAYED' WIRES' AND THE POTENTIAL CAUSE OF FAILURE 'INADEQUATE SPECIFICATION, WIRE INSULATION HAS INSUFFICIENT STRENGTH TO WITHSTAND DAMAGE DURING NORMAL USE AND REASONABLY FORESEEABLE MISUSE.' A SUPPLIER CORRECTIVE ACTION REQUEST WAS RAISED ON (B)(6) 2025 TO INVESTIGATE THE TREND OF COMPLAINTS RELATED TO THE CABLE OF THE POWER SUPPLY OF THE K-FTH-1012 DEVICE. THIS IS CURRENTLY IN PROGRESS. 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.

    Description of Event or Problem · 0

    THE REPLACEMENT POWER LEAD LOT NUMBER AM111170 (FOR A K-FTH-1012 TEST TUBE WARMER DEVICE) IS BECOMING FRAYED AND ELECTRICAL WIRES EXPOSED DESPITE US BEING PARTICULARLY CAREFUL ABOUT KEEPING THE WIRES STRAIGHT AND FLAT.

    Description of Event or Problem · 0

    THE REPLACEMENT POWER LEAD LOT NUMBER AM111170 (FOR A K-FTH-1012 TEST TUBE WARMER DEVICE) IS BECOMING FRAYED AND ELECTRICAL WIRES EXPOSED DESPITE US BEING PARTICULARLY CAREFUL ABOUT KEEPING THE WIRES STRAIGHT AND FLAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786556 TEST TUBE HEATER MQG ACCESSORY, ASSISTED REPRODUCTION - COOK TEST TUBE HEATER MQG WILLIAM A. COOK AUSTRALIA, PTY LTD AM111170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown