BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT MONITOR WITH INDEPENDENT REMOTE DISPLAY

    MDR report key: 12476393 · Received September 15, 2021

    Report

    Report Number
    3012307300-2021-09377
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 5, 2021
    Report Date
    May 9, 2023
    Manufacturer
    NULL
    Product Code
    QLJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2021-09377. THE REPORT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEST DATA COLLECTION CAME OUT IN (B)(6) BUT THE BOARD WAS TESTED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376326 PATIENT MONITOR WITH INDEPENDENT REMOTE DISPLAY QLJ 4103617

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown