FDA Adverse Event
Death
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 1617199
·
Received February 23, 2010
Report
- Report Number
- 1525712-2010-00024
- Event Type
- Death
- Date Received
- February 23, 2010
- Date of Event
- February 2, 2010
- Report Date
- February 22, 2010
- Manufacturer
- INVACARE
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A USERS SPOUSE CONTACTED MANUFACTURER ALLEGING HIS WIFE BECAME ENTRAPPED IN HER BED RAIL AND REPORTEDLY SUFFOCATED. DETAILS OF THE ALLEGED EVENT HAVE NOT BEEN PROVIDED. NO SERIAL NUMBER HAS BEEN PROVIDED. AGE OF DEVICE IS UNK. ZONE OF ENTRAPMENT IS UNK. MDR FILED BASED ON ALLEGED DEATH.
Description of Event or Problem · 1
THE CONSUMER'S HUSBAND ALLEGES THE BED ALLOWED HIS WIFE'S HEAD TO GET STUCK BETWEEN THE RAIL AND MATTRESS CAUSING HER TO SUFFOCATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE | 5410IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |