FDA Adverse Event
Malfunction
Summary report: N
ENTERPRISE 8000
MDR report key: 2111016
·
Received April 21, 2011
Report
- Report Number
- 3003984900-2011-00012
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 22, 2011
- Manufacturer
- ARJOHUNTLEIGH
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
AN ARJOHUNTLEIGH SERVICE TECH ATTENDED THE CLIENT'S PREMISES TO REPAIR AN ENTERPRISE 8000 BED. AFTER INSPECTION OF THE BED, HE HAD FOUND THAT THE THREAD BOSS INSIDE THE CASTING OF THE LHS BACKREST HINGE HAD BROKEN/SHEARED OFF, ALLOWING THE HINGE TO SEPARATE. THIS HAS RESULTED IN THE BACKREST BECOMING MISALIGNED. IT WAS ALSO FOUND THE LA27 BACKREST ACTUATOR ITSELF HAS ALSO FAILED TO EXTEND OR RETRACT UNDER ITS OWN POWER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE 8000 | MEDICAL BED | FNL | ARJOHUNTLEIGH | 8000BE42A22LA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |