FDA Adverse Event
Injury
Summary report: N
ROTAFLOW CONSOLE
MDR report key: 4580482
·
Received March 4, 2015
Report
- Report Number
- 3008355164-2015-00035
- Event Type
- Injury
- Date Received
- March 4, 2015
- Date of Event
- February 9, 2015
- Report Date
- February 9, 2015
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- KFM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE DEVICE WAS INVESTIGATED BY A MAQUET SERVICE TECHNICIAN. THE PUSH BUTTON KNOB WOULD NOT CONSISTENTLY TURN THE POTENTIOMETER. THE ROTARY-PUSH KNOB WAS REPLACED. THE DEVICE WAS RETURNED TO SERVICE. (B)(4). REFERENCE MFR # 8010762-2015-00237.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KNOB ON THE DEVICE FELT STICKY, STIFF AND DID NOT FREE SPIN AS THE OTHERS. ADDITIONAL INFO: DEVICE WAS REPLACED DURING TREATMENT. (B)(4). MFR REF # 8010762-2015-00237.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152222 | ROTAFLOW CONSOLE | ROTAFLOW ENGLISH/US US-PLUG ICU | KFM | MAQUET CARDIOPULMONARY AG | 70105.1712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |