FDA Adverse Event
Malfunction
Summary report: N
CIRRUS 600
MDR report key: 6669640
·
Received June 27, 2017
Report
- Report Number
- 6669640
- Event Type
- Malfunction
- Date Received
- June 27, 2017
- Date of Event
- June 15, 2017
- Report Date
- June 16, 2017
- Manufacturer
- TOLLOS, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MRI REPORTS THAT OVER THE LAST 3-4 MONTHS THE OVERHEAD LIFT IN MRI WILL ABRUPTLY STOP WORKING AND SAY EITHER NO OR LOW CHARGE EVEN THOUGH IT HAS BEEN IN THE CHARGING POSITION WHILE NOT IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451281 | CIRRUS 600 | LIFT, PATIENT, NON-AC POWERED | FSA | TOLLOS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |