BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFFINITY 1 & 2 BED

    MDR report key: 2630776 · Received June 21, 2012

    Report

    Report Number
    1824206-2012-03582
    Event Type
    Other
    Date Received
    June 21, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    HILL-ROM INC
    Product Code
    HDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED THE INCIDENT AND STATED THAT ALL THE SIDERAILS WORKED PROPERLY AND THE NURSE STATED THAT ALL THE SIDERAILS WERE UP AND LOCKED. NO ALLEGED DEFICIENCY WITH THE BED. NO OTHER INCIDENT WAS ALLEGED.

    Description of Event or Problem · 1

    THE NURSE ALLEGED THAT SHE HEARD OF AN INSTANCE WHEN A MONITOR WAS HOLDING A BABY IN A BIRTHING BED, AND THE MOTHER FELL ASLEEP, AND THE BABY FELL TO THE FLOOR. NO OTHER DETAILS WERE GIVEN. THE NURSE COULD NOT SAY WHEN THE ALLEGED INCIDENT HAD OCCURRED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 1 & 2 BED BIRTHING BED HDD HILL-ROM INC 3600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other