FDA Adverse Event
Injury
Summary report: N
VERSACARE
MDR report key: 1802569
·
Received August 10, 2010
Report
- Report Number
- 1824206-2010-09256
- Event Type
- Injury
- Date Received
- August 10, 2010
- Date of Event
- July 4, 2010
- Report Date
- July 16, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH SPOKE WITH THE ACCOUNT WHO STATED, THE PATIENT WAS FOUND ON THE FLOOR BY A DOCTOR. THEY CHECKED THE PATIENT OUT AND PLACED THE PT BACK IN BED. THE NURSE STATED THAT SHE ATTEMPTED TO SET THE BED EXIT BUT BELIEVES THAT SHE DID IT INCORRECTLY. THE ACCOUNT COULD NOT PROVIDE A SERIAL NUMBER AND WOULD NOT MAKE THE BED AVAILABLE FOR THE TECH TO INSPECT. THE ACCOUNT STATED THEY FELT THIS ISSUE WAS CAUSED BY USER ERROR. NO ADD'L INFO REGARDING THE INJURY WAS PROVIDED BY THE ACCOUNT.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT ON (B)(6), 2010, A PATIENT FELL AND BROKE THEIR HIP. THE BED WAS BEING USED IN ACUTE CARE, THE PT WEIGHTED (B)(6) AND THE PT POSITIONING MONITOR WAS ARMED. AN ENVISION MATTRESS WAS BEING USED ON THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE | AC POWERED HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |