BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3810301 · Received April 10, 2014

    Report

    Report Number
    1824206-2014-01142
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 13, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THERE WAS A PT FALL AND THE PT COMPLAINED OF PAIN BUT NO INJURIES. THE TECH PERFORMED THE INVESTIGATION AND THE ACCOUNT REPORTED THAT WHEN THE PT WENT TO USE THE NURSE CALL ON THE BED, IT DID NOT FUNCTION. THE PT THEN GOT UP FROM THE BED AND FELL TO THE FLOOR. THE PT DID NOT REPORT ANY INJURIES TO THE STAFF. THE NURSE REPORTED THAT SHE CALLED ANOTHER NURSE TO THE PT ROOM FOR HELP GETTING THE PT UP OFF THE FLOOR. THE NURSE STATED THAT SHE WAS ACROSS THE HALL AND HEARD THE PT SCREAM. WHEN SHE WENT INTO THE ROOM, THE PT WAS SITTING ON THE FLOOR. THE NURSE ASKED WHAT HAPPENED AND THE PT RESPONDED THAT, "I HAVE TO PUT THEM BOYS TO BED", THE NURSE STATED THAT THE PT IS ELDERLY AND WAS CONFUSED. THE PT WAS PUT BACK INTO THE BED AND THE BED EXIT WAS SET. THE NURSE STATED THAT THE BED EXIT WENT OFF SEVERAL TIMES THROUGH THE NIGHT WHEN THE PT WOULD TRY TO GET UP, BUT SHE CANNOT REMEMBER IF THE BED EXIT WAS SET TO BEGIN WITH OR NOT. THE CUSTOMER X-RAYED THE PT AND THE X-RAYS WERE NEGATIVE.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE NURSE CALL WAS NOT FUNCTIONING AND THE BED EXIT WOULD NOT SET ON THE BED. THE BED WAS LOCATED IN (B)(4) AT THE FACILITY. THE ACCOUNT STATED, THE BED WAS SWAPPED OUT DUE TO A PT FALL OR DUE TO THE RISK OF PT FALL. THE TECH REQUESTED FOR THE ACCOUNT TO FIND OUT COME DETAILS ON THE PT FALL AND IF THERE IS AN INJURY CONTRIBUTED BY THE FALL. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4). THE TECH REPORTED THAT THE NURSE CALL FEATURE FUNCTIONED UPON INSPECTION OF THE BED, THE BED EXIT ALSO FUNCTIONS AS DESIGNED. THE TECH REPORTED THAT WHEN THE BED EXIT ALARMED, A NURSE CALL WAS SENT TO THE NURSE STATION. HILL-ROM REP SPOKE WITH THE (B)(4) AND HE STATED THERE WAS A PT FAIL WITH NO INJURY TO THE PT BUT HE DID NOT KNOW OF ANY ALLEGATION OF THE BED MALFUNCTIONING. HE WAS NOT AWARE THE NURSES WERE USING THE BED EXIT ALARM AND HE BELIEVES THEY SHOULD BE USING THE BED CHECK METHOD TO ENSURE THE PTS ARE SAFETY. NO REPAIR WAS MADE DUE TO THE BED WAS FOUND TO FUNCTION AS DESIGNED. BASED ON THE INFO, NO FURTHER ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216329 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1