BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELCH ALLYN CONNEX 6800 VITAL SIGNS MONITOR

    MDR report key: 19126077 · Received April 16, 2024

    Report

    Report Number
    MW5153907
    Event Type
    Injury
    Date Received
    April 16, 2024
    Report Date
    April 12, 2024
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WELCH ALLYN CONNEX 6800 VITAL SIGNS MONITOR FELL OFF THE WALL MOUNTED ARM AND ADAPTER BRACKET. THIS IS THE 3RD TIME IN 4 MONTHS THAT THIS HAS OCCURRED IN ONE PATIENT CARE AREA (FLOOR A1) WHICH HAS 28 OF THESE WALL MOUNTED MONITORS. IT APPEARS THAT OVER TIME, THROUGH NORMAL MANIPULATION OF THE MONITOR, THE THUMBSCREW, THAT SECURES THE MONITOR TO THE BRACKET, LOOSENS AND THE BRACKET BECOMES BENT. THIS ALLOWS THE MONITOR TO RELEASE FROM THE BRACKET AND FALL. THESE ARE MOUNTED AT THE HEAD OF THE PATIENT BED AND CAN FALL ON PATIENTS AND CLINICAL STAFF. ONE OF THE 3 THAT HAS RECENTLY FALLEN, INJURED A NURSE. IN ANOTHER INPATIENT AREA (FLOOR A2), THE MOUNTING BRACKETS ON 6 OF THE 30 MONITORS HAD TO BE REPLACED DURING THE MONTH OF (B)(6) 2024 TO PREVENT THESE MONITORS FROM FALLING. REFERENCE REPORTS: MW5153905, MW5153906.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539378 WELCH ALLYN CONNEX 6800 VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MHX WELCH ALLYN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention