FDA Adverse Event
Malfunction
Summary report: N
RITTER
MDR report key: 2526956
·
Received March 30, 2012
Report
- Report Number
- 1523530-2012-00012
- Event Type
- Malfunction
- Date Received
- March 30, 2012
- Date of Event
- March 2, 2012
- Report Date
- March 30, 2012
- Manufacturer
- MIDMARK CORP.
- Product Code
- FQO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY AN INDEPENDENT SERVICE COMPANY. THE MALFUNCTION COULD NOT BE DUPLICATED. THE PRODUCT IS BEING RETURN FOR FURTHER EVALUATION.
Description of Event or Problem · 1
FACILITY CLAIMS THE TABLE LOWERED ON ITS OWN. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RITTER | EXAMINATION TABLE | FQO | MIDMARK CORP. | 222-015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |