BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 3924709 · Received June 25, 2014

    Report

    Report Number
    3006697241-2014-00526
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT TROUBLESHOT WITH THE ACCOUNT. THEY ISOLATED AND DETERMINED THE HAND PENDANT WAS THE ISSUE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED MOVED INTO THE CHAIR POSITION UNINTENTIONALLY. THE BED WAS LOCATED ON THE 3RD FLOOR MED SURG DEPARTMENT. THERE WAS NO PATIENT/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
    369818 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