BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE P500 NSC AIR RENTAL BED

    MDR report key: 3880499 · Received May 30, 2014

    Report

    Report Number
    1824206-2014-01673
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 3, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THAT THE SCALE WAS ZEROED WITH A PT IN THE BED CAUSING BOTH ISSUES, USER ERROR. THE TECH ZEROED THE SCALE WITHOUT A PT IN THE BED AND IN-SERVICED THE NURSE ON THE BED EXIT FUNCTIONS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BED EXIT WOULD NOT SET AND THE SCALE WAS NOT FUNCTIONING. THE BED WAS LOCATED IN ROOM 613 AT THE FACILITY. 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
    319884 VERSACARE P500 NSC AIR RENTAL BED A/C POWERED ADJUSTABLE HOSP BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1