FDA Adverse Event
Malfunction
Summary report: N
ENTERPRISE 9000
MDR report key: 2223515
·
Received July 14, 2011
Report
- Report Number
- 3003984900-2011-00021
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 15, 2011
- Manufacturer
- ARJOHUNTLEIGH
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ((B)(4)) ON BEHALF OF THE MFR ARJOHUNTLEIGH, A BRANCH OF ARJO (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
ENTERPRISE BED ALARM WAS NOT WORKING. THE STAFF SET THE ALARM WHEN THE RESIDENT WENT TO BED BUT IT SHUT ITSELF OFF UNCOMMANDED OR WAS NOT WORKING BECAUSE THE RESIDENT GOT OUT OF BED WITHOUT THE ALARM GOING OFF. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE 9000 | MEDICAL BED | FNL | ARJOHUNTLEIGH | 9800BA22A12BM8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |