FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM
MDR report key: 3813195
·
Received March 26, 2014
Report
- Report Number
- 1828100-2014-00232
- Event Type
- Malfunction
- Date Received
- March 26, 2014
- Date of Event
- February 25, 2014
- Report Date
- March 3, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS 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
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE SERVICE REPAIR TECH (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SUBSIDIARY SERVICE CENTER, THE CENTRAL CONTROL MONITOR (CCM) FAILED TO START-UP. THIS IS ON MANUFACTURER DEMO UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177662 | TERUMO ADVANCED PERFUSION SYSTEM | APS 1 (CCM) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 802100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |