BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4 BIRTHING BED

    MDR report key: 3071181 · Received April 9, 2013

    Report

    Report Number
    1824206-2013-02048
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE HEAD WALL UNIT HAD A FLOOR STEP INSTALLED WHICH CAUSED THE COMMUNICATION JUNCTION BOX AND SIDECOM CABLE TO BE DAMAGED WHEN BED WAS LOWERED WHILE IN THE TRENDELENBURG POSITION. THIS WAS A HILL-ROM HEAD WALL. THE TECHNICIAN STATED THE FLOOR STEP WAS REMOVED FROM THE WALL UNIT TO PREVENT FURTHER DAMAGE TO THE BED AND THE JUNCTION BOX AND SIDECOM CABLE WERE REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE NURSE CALL DID NOT FUNCTION. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147933 AFFINITY 4 BIRTHING BED BIRTHING BED HDD HILL-ROM, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1