BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU40 DEVICE

    MDR report key: 7943436 · Received October 8, 2018

    Report

    Report Number
    8010762-2018-00274
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    September 12, 2018
    Report Date
    April 11, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER: MAQUET MEDICAL SYSTEMS USA. 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE SERVICE TECHNICIAN WAS ON-SITE TO PERFORM FURTHER INVESTIGATION. ACCORDING TO THE SERVICE REPORT DATED ON 2019-03-06, IT WAS FOUND THAT THE DEVICE BOARD OF THE POWER SUPPLY HAS A SHORT CIRCUIT. THE SERVICE TECHNICIAN REPLACED THE DEFECTIVE DEVICE BOARD AND CLEANED THE VACUUM VALVE. THE DEFECTIVE BOARD HAS BEEN REQUESTED FOR RETURN IN ORDER TO PERFORM FURTHER INVESTIGATION IN OUR LIFE CYCLE ENGINEERING (LCE).

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON- (B)(6). A MCP FIELD SERVICE TECHNICIAN WAS ON SITE AND CARRIED OUT SERVICE ON THE DEVICE ON (B)(6) 2018. DEVICE WAS INSPECTED, TROUBLESHOOTING REVEALED THAT THE DEVICE BOARD AT THE POWER SUPPLY HAD A SHORT CIRCUIT. FAULTY DEVICE BOARD REPLACED AND VACUUM VALVE CLEANED. PERFORMED AGAIN A INSPECTION AND ALL TESTS PASSED. UNIT WAS CLEARED FOR CLINICAL USE. THE DEFECTIVE PART (DEVICE BOARD) WAS NO LONGER AVAILABLE TO PERFORM FURTHER INVESTIGATIONS IN OUR LIFE CYCLE ENGINEERING. THEREFORE NO ROOT CAUSE COULD BE DETERMINED. HOWEVER, THE FAILURE COULD BE CONFIRMED. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS A SYSTEMIC ERROR. NO CORRECTIVE ACTION IS NEEDED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4). (B)(6).

    Description of Event or Problem · 0

    REF.: (B)(4). CUSTOMER REF.: (B)(4).

    Description of Event or Problem · 0

    REF.: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HCU40 BANG AND BURNING SMELL DURING PATIENT TREATMENT. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784406 MAQUET HCU40 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG 701044054

    Patients

    Seq Age Sex Outcome Treatment
    1