FDA Adverse Event
Summary report: N
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
MDR report key: 4130088
·
Received September 30, 2014
Report
- Report Number
- 1531186-2014-04578
- Date Received
- September 30, 2014
- Report Date
- September 11, 2014
- Manufacturer
- GRAND HEALTHCARE CO., LTD.
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
UNIT DOES NOT HAVE ENOUGH PRESSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608202 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | 880.5550 | FNM | GRAND HEALTHCARE CO., LTD. | CG9701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |