FDA Adverse Event
Other
Summary report: N
AMBASSADOR 1200
MDR report key: 746300
·
Received October 3, 2005
Report
- Report Number
- MW1036824
- Event Type
- Other
- Date Received
- October 3, 2005
- Date of Event
- September 27, 2005
- Report Date
- October 3, 2005
- Manufacturer
- SAFE-TCARE MANUFACTURING, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT WAS HOLDING ONTO SIDE RAIL-HE USED IT FOR POSITIONING. WE BELIEVE THAT HE WAS SLEEPING AND PULLED HIMSELF USING THE SIDE RAIL AND AS THE RELEASE IS LOCATED ON THE TOP OF THE RAIL HE ACCIDENTALLY PULLED THE RELEASE AND THIS CAUSED THE RAIL TO LOWER AND HE MUST HAVE HELD ON AND WHEN HIS WEIGHT SHIFTED IT PULLED HIM OUT OF BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMBASSADOR 1200 | BARIATRIC BED | FNL | SAFE-TCARE MANUFACTURING, INC. | AB 1200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |