FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2060899
·
Received March 14, 2011
Report
- Report Number
- 1828100-2011-00627
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- February 18, 2011
- Report Date
- March 14, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SVC REP REPORTED THAT THE HEART LUNG CONSOLE FAILED TO POWER UP USING BATTERY POWER, EVEN AFTER SEVERAL HOURS OF CHARGING THE CONSOLE. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | HEART LUNG CONSOLE | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |