BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET HCU30

    MDR report key: 4188783 · Received October 17, 2014

    Report

    Report Number
    8010762-2014-00811
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER SERVICE REPORT (B)(4) THE DEVICE WAS EVALUATED BY A (B)(4) TECHNICIAN. THE TECHNICIAN REPLACED A DEFECTIVE 20 AMP BREAKER THAT WAS SWOLLEN. FUNCTIONAL TESTING WAS PERFORMED TO FACTORY SPECIFICATIONS. THE DEVICE WAS RETURNED TO SERVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A MAQUET SERVICE TECHNICIAN. THE TECHNICIAN REPLACED A DEFECTIVE 20 AMP BREAKER THAT WAS SWOLLEN. FUNCTIONAL TESTING WAS SUCCESSFULLY PERFORMED TO FACTORY SPECIFICATIONS. THE DEVICE WAS RETURNED TO USE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A MAQUET SERVICE TECHNICIAN. THE TECHNICIAN REPLACED A DEFECTIVE 20 AMP BREAKER THAT WAS SWOLLEN. FUNCTIONAL TESTING WAS SUCCESSFULLY PERFORMED TO FACTORY SPECIFICATIONS. THE DEVICE WAS RETURNED TO USE.

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH IS EVALUATING THE DEVICE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    (B)(4). THIS IS A FOLLOW-UP #2 FOR THE INITIAL REPORT MFR # 8010762-2014-00811 AND IMPORTER # (B)(4) SUBMITTED ON OCTOBER 20,2014. THEN ANOTHER INITIAL WAS ERRONEOUSLY SUBMITTED UNDER MFR # 8010762-2016-00185 AND IMPORTER # (B)(4) ON MARCH 16,2016. THIS SUBMISSION AS FOLLOW-UP #2, SERVES TO CORRECT THAT ERROR. FDA CORRESPONDENCE STATED THAT ALL FOLLOW-UP MEDWATCHES MUST BE FILED ELECTRONICALLY.

    Description of Event or Problem · 1

    (B)(4). THIS IS A RESUBMISSION FOR MFR # 8010762-2014-00811 AND IMPORTER # 3008355164-2014-00163 WHICH WAS INADVERTENTLY REPORTED AS 8010762-2016-00185 AND 3008355164-2016-00026 ON MARCH 16,2016.

    Description of Event or Problem · 1

    (B)(4). THIS IS A RESUBMISSION FOR MFR # 8010762-2014-00811 AND IMPORTER # (B)(4) WHICH WAS INADVERTENTLY REPORTED AS 8010762-2016-00185 AND (B)(4) ON MARCH 16, 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE TRIPPED THE 20 AMP BREAKER THREE TIMES DURING USE. A BACKUP SYSTEM WAS USED AND THE DEFECTIVE SYSTEM WAS REMOVED FROM SERVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661135 MAQUET HCU30 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG MCP00939001

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention