FDA Adverse Event
Malfunction
Summary report: N
ENTERPRISE 8000
MDR report key: 2540597
·
Received April 16, 2012
Report
- Report Number
- 3003984900-2012-00015
- Event Type
- Malfunction
- Date Received
- April 16, 2012
- Date of Event
- February 19, 2012
- Report Date
- February 20, 2012
- Manufacturer
- ARJOHUNTLEIGH MEDICAL BEDS DIVISION
- Product Code
- FNL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- 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 MEDICAL BEDS DIVISION. (B)(4). ADD¿L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR¿S INVESTIGATION.
Description of Event or Problem · 1
CONTROLPANEL ALL LIT UP. WHEN NURSES TRIED TO LOCK UP PANEL IT DID NOT WORK. IN MEANTIME BED STARTED TO GO INTO CHOCKPOSITION. NURSES TRIED TO PULL HLR HANDLE TO GET BED INTO FLAT POSITION BUT IT DID NOT WORK. THEY ALSO TRIED TO PULL ELECTRICAL CORD AND REINSERT BUT THE BED WENT INTO FULL CHOCKPOSITION. PT GOT DIFFICULTIES BREATHING AND NURSES HAD TO MOVE THIS VERY ILL PATIENT TO ANOTHER BED WITH HELP OF LIFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE 8000 | MEDICAL BED | FNL | ARJOHUNTLEIGH MEDICAL BEDS DIVISION | 8000BC22A21BA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |