FDA Adverse Event
Malfunction
Summary report: N
TREATMENT RECLINER
MDR report key: 2231502
·
Received July 22, 2011
Report
- Report Number
- 1831750-2011-07504
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 23, 2011
- Manufacturer
- GLOBAL
- Product Code
- FRK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVAL RESULT: RECLINER MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE RECLINER WAS GOING INTO TREND AUTOMATICALLY. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TREATMENT RECLINER | EXAMINATION AND TREATMENT CHAIR | FRK | GLOBAL | 3500000710 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |