FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2915423
·
Received January 9, 2013
Report
- Report Number
- 1828100-2013-00013
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 6, 2012
- Report Date
- December 14, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROCESS, BUT NOT YET COMPLETE.
Description of Event or Problem · 1
A SUBSIDIARY REPRESENTATIVE REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THERE WAS NO DISPLAY ON THE CENTRAL CONTROL MONITOR. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12688 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP | 816300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |