BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFFINITY 3

    MDR report key: 1564235 · Received December 16, 2009

    Report

    Report Number
    1824206-2009-07416
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    November 22, 2009
    Report Date
    November 23, 2009
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MIDWIFE ALLEGED SHE WAS IN LABOR AND DELIVERY 3 DURING A PT DELIVERY. SHE SAT ON THE RIGHT EDGE OF THE FOOT SECTION WELDMENT AND AFTER 3 TO 40 MINUTES, THE FOOT SECTION WELDMENT FELL TO THE FLOOR, CAUSING HER TO FALL ON THE FLOOR. THE MIDWIFE HAD A CT SCAN WHICH ACCORDING TO HOSPITAL CAME BACK WITH NO INJURY AND NO TREATMENT WAS PROVIDED. THE TECHNICIAN LATCHED AND UNLATCHED THE FOOT SECTION WELDMENT FIVE TIMES AND PLACED HIS FULL BODY WEIGHT ((B) (6)) ON THE FOOT SECTION WELDMENT. THE TECHNICIAN FOUND THE FOOT SECTION WAS OPERATING NORMALLY WITH NO ABNORMAL OPERATION. THE TECHNICIAN FOUND NO DAMAGE TO THE FOOT SECTION EXCEPT THE LEFT RELEASE HANDLE WAS BENT SLIGHTLY, BUT DID NOT AFFECT THE OPERATION OF THE LATCHING OR UNLATCHING. THE STAFF COULD NOT CONFIRM IF THE FOOT SECTION WAS PROPERLY LATCHED ON THE BED. THE TECHNICIAN TRAINED THE STAFF ON THE PROPER LATCHING OF THE FOOT SECTION.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT ONE OF THE DOCTORS SAT ON THE FOOT SECTION OF THIS BED AND THE FOOT SECTION FELL TO THE FLOOR. HE INDICATED THAT THE DOCTOR WAS INJURED FROM THIS FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 3 BIRTHING BED HDD HILL-ROM RITTER 3700

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR