FDA Adverse Event
Malfunction
Summary report: N
XPRT SLEEP SURFACE
MDR report key: 2031689
·
Received February 24, 2011
Report
- Report Number
- 1313850-2011-00016
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 26, 2011
- Manufacturer
- GAYMAR INDUSTRIES, INC.
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
LEAK.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE STOP COVER IS LEAKING FLUID INTO THE AIR CELLS. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPRT SLEEP SURFACE | MATTRESS | FNM | GAYMAR INDUSTRIES, INC. | 2950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |