BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T.W. POWER SUPPLY

    MDR report key: 5075253 · Received September 14, 2015

    Report

    Report Number
    2242352-2015-01070
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Report Date
    August 17, 2015
    Manufacturer
    MAQUET CV
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4) 2015 11:05 AM (GMT-5:00) ADDED BY (B)(4): THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE VASOVIEW HEMOPRO POSTER SUPPLY KNOB IS MISSING. CUSTOMER STATED HE DID NOT KNOW HOW THE POWER SUPPLY LOST ITS KNOB. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE VASOVIEW HEMOPRO POSTER SUPPLY KNOB IS MISSING. CUSTOMER STATED HE DID NOT KNOW HOW THE POWER SUPPLY LOST ITS KNOB. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605765 T.W. POWER SUPPLY UNIT, CAUTERY, THERMAL, AC-POWERED HQO MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1