BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANOMETER, BLOOD-PRESSURE, VENOUS

    MDR report key: 17535826 · Received August 12, 2023

    Report

    Report Number
    MW5142720
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 28, 2018
    Manufacturer
    VORTECH
    Product Code
    KRK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE DOCTOR (B)(6) REPORTED THAT ONE OF THE PRESSURE REGULATORS (MANOMETER) THAT IS PERMANENTLY IN THE HOSPITAL IS BROKEN, AND HE DID NOT GIVE MORE INFORMATION. DOCTOR: (B)(6) - HOSPITAL : (B)(6) PRODUCT: 50182532 PROCEDURE: UNKNOWN (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785014 MANOMETER, BLOOD-PRESSURE, VENOUS MANOMETER, BLOOD-PRESSURE, VENOUS KRK VORTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown