FDA Adverse Event
Malfunction
Summary report: N
ENTERPRISE RANGE
MDR report key: 1993141
·
Received February 10, 2011
Report
- Report Number
- 3003984900-2011-00003
- Event Type
- Malfunction
- Date Received
- February 10, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 26, 2011
- Manufacturer
- ARJOHUNTLEIGH
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED PENDING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
WE HAVE RECEIVED A REPORT FROM (B)(6) TRUST THAT THE BACKREST ON ONE OF OUR ENTERPRISE 8000 MODEL BEDS HAD OPERATED WITHOUT A COMMAND BEING GIVEN. AN INCIDENT OCCURRED IN THE ICU DEPARTMENT; IT WAS REPORTED THAT THE PROFILING BED MOVED POSITON WITHOUT ANY CONTACT BY PT, STAFF OR RELATIVES. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE RANGE | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | ARJOHUNTLEIGH | 8000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |