FDA Adverse Event
Malfunction
Summary report: N
OAKWORKS MEDICAL CFPM 300 IMAGING TABLE
MDR report key: 6660067
·
Received June 22, 2017
Report
- Report Number
- 2529571-2017-00010
- Event Type
- Malfunction
- Date Received
- June 22, 2017
- Date of Event
- December 17, 2015
- Report Date
- June 6, 2017
- Manufacturer
- OAKWORKS, INC.,
- Product Code
- IXR
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
(B)(6) FROM (B)(6) CALLED IN AND SAID THAT DR. (B)(6) HAS A PATIENT STUCK ON THE TABLE IN THE UP POSITION. (B)(6) CALLED THE DOCTOR AND THE FOOT PEDAL WAS STUCK UNDER THE TABLE. THERE IS NO PATIENT HARM OR ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440503 | OAKWORKS MEDICAL CFPM 300 IMAGING TABLE | IMAGING TABLE | IXR | OAKWORKS, INC., | CFPM 300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |