FDA Adverse Event
Malfunction
Summary report: N
MIDMARK
MDR report key: 2464068
·
Received February 15, 2012
Report
- Report Number
- 1523530-2012-00004
- Event Type
- Malfunction
- Date Received
- February 15, 2012
- Date of Event
- January 23, 2012
- Report Date
- February 15, 2012
- Manufacturer
- MIDMARK CORP.
- Product Code
- FQO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RETURNED AT THIS TIME. AN INVESTIGATION WILL BE CONDUCTED WHEN THE PRODUCT IS RETURNED.
Description of Event or Problem · 1
THE FACILITY STAFF CLAIMS THE TABLE CONTINUED TO RUN, BACK AND BASE UP, AFTER THE CONTROL WAS RELEASED. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIDMARK | EXAMINATION TABLE | FQO | MIDMARK CORP. | 630-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |