BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET EGB40 DEVICE

    MDR report key: 7381327 · Received March 29, 2018

    Report

    Report Number
    8010762-2018-00117
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    March 13, 2018
    Report Date
    April 12, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K948303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE WAYNE, NJ 07470 . CONTACT PERSON- (B)(6). AFTER REVIEWING, WE FOUND THAT THE EGB 40 DOES NOT POSE A RISK TO THE PATIENT. SINCE THE DEVICE IS NOT DIRECTLY CONNECTED TO THE PATIENT. THERE IS NO SIMILAR DEVICE CURRENTLY ON THE MARKET IN THE USA. FURTHERMORE, THE EGB 40 IS GENERALLY NOT A REPORTABLE PRODUCT. THIS CASE HAS BEEN FALSELY REPORTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: IT WAS REPORTED THAT FIO2 CAME DOWN, DEVICE ALARMING FROM THE EGB 40. ADDITIONAL INFORMATION: THE INCIDENT OCCURRED DURING PATIENT TREATMENT. DEVICE HAS BEEN REPLACED DURING TREATMENT. NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223523 MAQUET EGB40 DEVICE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG EGB40

    Patients

    Seq Age Sex Outcome Treatment
    1