FDA Adverse Event
Summary report: N
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
MDR report key: 2832798
·
Received November 14, 2012
Report
- Report Number
- 1531186-2012-01397
- Date Received
- November 14, 2012
- Report Date
- November 12, 2012
- Manufacturer
- GRAND HEALTHCARE CO., LTD.
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4) - THE DEALER REPORTED THAT THE CG9701 CARE GUARD PUMP AND PAD WOULD NOT FULLY INFLATE. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | 880.5550 | FNM | GRAND HEALTHCARE CO., LTD. | CG9701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |