FDA Adverse Event
Malfunction
Summary report: N
MIDMARK
MDR report key: 1760680
·
Received July 14, 2010
Report
- Report Number
- 1523530-2010-00003
- Event Type
- Malfunction
- Date Received
- July 14, 2010
- Date of Event
- June 18, 2010
- Report Date
- July 14, 2010
- Manufacturer
- MIDMARK CORP.
- Product Code
- EAZ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE SUSPENSION TUBE FROM THE MONITOR TROLLEY FELL. NO ONE WAS HURT. THE DOCTOR AND THE PATIENT CAUGHT THE FLEX ARM AND SUSPENSION TUBE AS IT FELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIDMARK | LIGHT, OPERATING, DENTAL | EAZ | MIDMARK CORP. | 029-4739-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |