FDA Adverse Event
Summary report: N
NOA (ONYX)
MDR report key: 115297
·
Received August 1, 1997
Report
- Report Number
- 115297
- Date Received
- August 1, 1997
- Date of Event
- June 19, 1997
- Report Date
- July 21, 1997
- Manufacturer
- NOA MEDICAL INDUSTRIES, INC.
- Product Code
- FNJ
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EMPLOYEE WAS TYING A RESTRAINT ON THE HEAD OF THE BED. THE HEAD OF THE BED WAS IN THE ELEVATED POSITION. THE SUPPORTING HEAD ELEVATION BAR WAS IN A 90 DEGREE POSITION, (AT THIS 90 DEGREE POSITION, SUPPORT BAR, POSSIBLE DUE TO THE WEIGHT, GIVES THE IMPRESSION THAT IT IS IN A LOCKED POSITION). WHILE TYING THE RESTRAINT, THE EMPLOYEE BUMPED THE SUPPORT BAR FORWARD TOWARDS THE FOOT OF THE BED. THE HEAD OF THE BED CAME DOWN ON THE EMPLOYEE'S RIGHT WRIST, BREAKING IT. STAFF HAS BEEN IN-SERVICED AS TO THE ONE AND ONLY PROPER POSITION OF THE ELEVATED HEAD REST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOA (ONYX) | LOW BED | FNJ | NOA MEDICAL INDUSTRIES, INC. | ONYX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |