BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREASSIST BED

    MDR report key: 3001265 · Received March 1, 2013

    Report

    Report Number
    3006697241-2013-00045
    Event Type
    Other
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED AND THE STAFF STATED THEY HAD SET THE BED EXIT ALARM AND RETURNED FIVE MINUTES LATER TO FIND THE PATIENT ON THE FLOOR NEXT TO THE BED AND THE PATIENT WAS UNINJURED. THE SCALE READ OUT INDICATED AN ERROR CODE ON THE SCREEN. THE ACCOUNT STATED THE PATIENT PENDANT WAS REMOVED BECAUSE IT WAS DAMAGE. THE TECHNICIAN INSPECTED THE BED AND FOUND ALL MODES OF THE PATIENT POSITON MODULE WAS FUNCTIONING AS DESIGNED. NO ACTIVE ERROR CODES IN THE SYSTEM. THE TECHNICIAN ASKED TO INSPECT THE DAMAGED HAND PENDANT, BUT THE ACCOUNT COULD NOT LOCATE THE EXACT PENDANT THAT WAS ON THE BED. THE TECHNICIAN COULD NOT DUPLICATE THE ISSUE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE PATIENT WAS FOUND ON THE FLOOR AND THE PATIENT POSITION MODULE DID NOT ALARM. NO INJURY DUE TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88865 CAREASSIST BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILLROM DE MEXICO S DE RL DE CV 1170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other