BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 3896800 · Received May 20, 2014

    Report

    Report Number
    3006697241-2014-00472
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 24, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BED'S SCALE HAD BEEN ZEROED WITH THE PT IN THE BED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN ZEROED THE SCALE TO RESOLVE THE ISSUE. THE TECHNICIAN THOROUGHLY TESTED THE BED EXIT SYSTEM AND IT FUNCTIONED AS DESIGNED. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED EXIT WOULD NOT SET. THE BED WAS LOCATED IN STANTON 3 HALFWAY AT THE ACCOUNT. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300723 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