FDA Adverse Event
Malfunction
Summary report: N
TERUMO TCM II COOLING AND HEATING SYSTEM
MDR report key: 2241007
·
Received August 17, 2011
Report
- Report Number
- 1828100-2011-02489
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 26, 2011
- Report Date
- August 17, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWC
- PMA / PMN Number
- K883603
- 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 ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECH REPORTED THAT THE DUAL TEMP SENSOR INSULATION WAS CRACKED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO TCM II COOLING AND HEATING SYSTEM | HEATING COOLING SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 4415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |