FDA Adverse Event
Other
Summary report: N
EZC MANUAL HOSPITAL BED
MDR report key: 238604
·
Received August 27, 1999
Report
- Report Number
- 2182305-1999-00017
- Event Type
- Other
- Date Received
- August 27, 1999
- Report Date
- August 25, 1999
- Manufacturer
- SUNRISE MEDICAL CCG, INC.
- Product Code
- FNJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT FACILITY CLAIMS RAIL CLIP WAS NOT CLIPPED IN ON THE SIDE OF THE RAIL PER INSTALLERS, AND THAT THE RAIL CAME LOOSE AND A PT FELL OUT OF BED. NUMEROUS ATTEMPTS HAVE BEEN MADE (PHONE AND FAXES) FOR ADDITIONAL INFO. AS OF THIS WRITING, NO REPLY HAS BEEN RECEIVED. THEREFORE, CO CAN ONLY ASSUME THE CLAIM WAS FALSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZC MANUAL HOSPITAL BED | MANUAL HOSPITAL BED W/RAILS | FNJ | SUNRISE MEDICAL CCG, INC. | 1/2 OR 3/4 SIZE RAIL | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |