BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO POWER SUPPLY

    MDR report key: 16826034 · Received April 27, 2023

    Report

    Report Number
    2242352-2023-00336
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 24, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    HQO
    UDI-DI
    00607567700826
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). UPDATED SECTIONS: B4, D10, G4, G7, H2, H3, H6, H10, H11. CORRECTED SECTIONS: H6--MEDICAL DEVICE ¿ PROBLEM CODE CORRECTED FROM CODE "1198" TO CODE "1211" A LOT HISTORY SEARCH IS NOT APPLICABLE BECAUSE THIS IS A REUSABLE, OEM DEVICE. DUE TO THE AGE OF THE DEVICE, A C OF C IS NOT READILY AVAILABLE ON-SITE. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (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.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT T.W. POWER SUPPLY S/N (B)(6) (WARRANTY EXPIRED FEB/17/2011) WAS NOT WORKING (FAILED TO SUPPLY ENERGY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612884 HEMOPRO POWER SUPPLY UNIT, CAUTERY, THERMAL, AC-POWERED HQO MAQUET CARDIOVASCULAR LLC C-VH-3010 00607567700826

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown