FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 3416469
·
Received September 30, 2013
Report
- Report Number
- 1828100-2013-00874
- Event Type
- Malfunction
- Date Received
- September 30, 2013
- Date of Event
- August 30, 2013
- Report Date
- September 9, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SUBSIDIARY'S MANUFACTURING ENGINEERING CENTER (MEC), THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) WOULD NOT CALIBRATE. ERROR CODE 23 2981 WAS OBSERVED. THIS UNIT IS A SERVICE CENTER'S DEMO/TRAINING UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493899 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP | 801188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |