BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 21285278 · Received January 31, 2025

    Report

    Report Number
    2242352-2025-0000078
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 3, 2025
    Report Date
    April 7, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    HQN
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW# (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    TW # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 01/27/2025. AN INVESTIGATION WAS CONDUCTED ON 02/17/2025. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT POWER SUPPLY. AN ELECTRICAL EVALUATION WAS CONDUCTED. A REFERENCE POWER CORD WAS PLUGGED INTO THE POWER SUPPLY AND THE DEVICE WAS SWITCHED ON. THE GREEN LIGHTS ON THE POWER SUPPLY WERE GREEN, INDICATION OF POWER TO THE REFERENCE DEVICE. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE ADAPTER, HP2, CABLE, AND POWER SUPPLY VH-3010 AT LEVEL 3.0. THE DEVICE PASSED THE PRE-CAUTERY TEST. VISIBLE STEAM OR HEAT WAS PRODUCED WHEN THE DEVICE WAS ACTIVATED AND TONE WAS AUDIBLE FROM THE POWER SUPPLY UPON ACTIVATION. AN ACTIVATION AND TRANSECTION CAPABILITY TEST WAS PERFORMED OVER FOUR (04) REPETITIONS USING "MAX LIFE TEST METHOD STM2048073. THE DEVICE SUCCESSFULLY TRANSECTED TISSUE FOUR (4) TIMES. BASED ON THE RETURNED CONDITION OF THE DEVICE AND ENGINEER EVALUATION, THE REPORTED FAILURE "ELECTRICAL PROBLEM" WAS NOT CONFIRMED. A MANUFACTURING EVALUATION WAS CONDUCTED. THE COMPLAINT WAS NOT CONFIRMED BY VERIFYING THE POWER SUPPLY "NO LOAD VOLTAGE" AND "LOW & HIGH CURRENT" OUTPUTS USING THE TEST STEPS OUTLINED IN THE EQUIPMENT CALIBRATION PROCEDURE FOR VASOVIEW HEMOPRO POWER SUPPLY, MCV00030545. THE VASOVIEW HEMOPRO POWER SUPPLY OPERATING RANGES AND TOLERANCES ARE AS FOLLOWS: NO LOAD VOLTAGE OUTPUT: 5.5 VDC +/- 0.05 VDC LOW CURRENT OUTPUT: 4.0 AMPS DC +/- 0.05 AMPS DC HIGH CURRENT OUTPUT: 6.0 AMPS DC +/- 0.05 AMPS DC THE COMPLAINT VASOVIEW HEMOPRO POWER SUPPLY WAS TESTED USING A KEYSIGHT MULTIMETER MODEL 34461A (BMRAM ID# 18487) AND THE COMPLAINT LAB'S HEMOPRO POWER SUPPLY TEST BOX, MCV00010390. THE TEST RESULTS WERE AS FOLLOWS: NO LOAD VOLTAGE OUTPUT: 5.51 VDC (PASSED TEST) LOW CURRENT OUTPUT: 4.00 AMPS DC (PASSED TEST) HIGH CURRENT OUTPUT: 6.00 AMPS DC (PASSED TEST) THE COMPLAINT VASOVIEW HEMOPRO POWER SUPPLY PASSED ALL THREE OUTPUT TESTS. BASED ON THE MANUFACTURING ENGINEERING EVALUATION, THE REPORTED FAILURE "ELECTRICAL PROBLEM" WAS NOT CONFIRMED. THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE SERIAL # (B)(6). THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL # CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS AND THERE WERE NO NON-CONFORMANCES IDENTIFIED FOR THE MANUFACTURING BATCH.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED DURING THE PROCEDURE, THAT THE T.W. POWER SUPPLY BOX WAS MAKING A STRANGE NOISE THEN STOPPED WORKING. CORDS WERE SWAPPED OUT AND ISOLATED PROBLEM TO THE ACTUAL POWER SUPPLY. USED ANOTHER VH-3010 TO COMPLETE THE PROCEDURE. PROCEDURAL DELAY TO TROUBLESHOOT BUT DIDN'T EXTEND OR TIME. NO PATIENT EFFECTS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495282 T.W. POWER SUPPLY CONFORMER, OPHTHALMIC HQN MAQUET CARDIOVASCULAR LLC VH-3010

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male CORDS| NO CONCOMITANT MEDICAL PRODUCTS