BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 4213867 · Received October 6, 2014

    Report

    Report Number
    3006697241-2014-00687
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE SIDE RAIL PIVOT PIN WAS MISSING. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013 AND 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECH REPLACED THE SIDE RAIL PIVOT PIN TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECH STATING THE RIGHT FOOT SIDE RAIL WOULD NOT LATCH. THE BED WAS LOCATED IN THE ACA WAREHOUSE 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
    625061 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