FDA Adverse Event Other Summary report: N

BED, HOSPITAL

MDR report key: 1040658 · Received May 8, 2008

Report

Report Number
2182305-2008-00017
Event Type
Other
Date Received
May 8, 2008
Date of Event
April 5, 2008
Report Date
May 2, 2008
Manufacturer
JOERNS HEALTHCARE, INC.
Product Code
FNJ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CT, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED TO MFR, BY FACILITY, PER FACILITY, THERE WAS ONE C.N.A. PRESENT AT THE TIME OF THE INCIDENT. RESIDENT WAS IN BED, BED WAS IN THE HIGHEST POSITION AND ALL FOUR RAILS WERE RAISED. ALLEGEDLY, WHILE THE C.N.A. WAS PROVIDING CARE TO THE RESIDENT, SHE ROLLED THE RESIDENT ON THEIR SIDE. THEN ALLEGEDLY, THE RESIDENT SOMEHOW ROLLED OFF THE OTHER SIDE OF THE BED AND FELL TO THE FLOOR. PER FACILITY, THE RESIDENT WENT THROUGH THE MIDDLE OF THE TWO SIDE RAILS. SIDE RAIL PADDING ALSO USED. ANOTHER MFR, CORNERSTONE MEDICAL AIR MATTRESS WAS ON THE BED AT TIME OF INCIDENT. NO RMA WAS ISSUED BECAUSE MFR OF BED/RAILS ARE SENDING OUR SERVICE TEAM (EMSAR) INTO FACILITY TO INSPECT THE BED AND RAILS PER THE FACILITY REQUEST. PER FIELD SERVICE REPORT FINDINGS OF 23, "BED IS FUNCTIONING AS INTENDED, NO MECHANICAL OR PHYSICAL DEFECTS FOUND, ALL FUNCTIONS OF THE UNIT ARE WORKING PROPERLY. IN ADDITION, WE INSPECTED AND REVIEWED THE SIDE RAILS, RAILS WERE LOCKING PROPERLY, NO DEFECTS FOUND WITH THE FAILS. THE BED AND RAILS ARE FUNCTIONING AS INTENDED."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BED, HOSPITAL BED, HOSPITAL, MANUAL FNJ JOERNS HEALTHCARE, INC. U770 W/F17TMAL 1/2 RAILS

Patients

Seq Age Sex Outcome Treatment
1 UNK Other