FDA Adverse Event
Malfunction
Summary report: N
TERUMO CENTRIFUGAL SYSTEM
MDR report key: 2961542
·
Received February 11, 2013
Report
- Report Number
- 1828100-2013-00121
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- DWA
- PMA / PMN Number
- K950739
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE BATTERIES ARE NOT HOLDING A CHARGE ON THE CENTRIFUGAL UNIT. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59994 | TERUMO CENTRIFUGAL SYSTEM | DWA | TERUMO CARDIOVASCULAR SYSTEM CORP | 9490 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |