FDA Adverse Event
Malfunction
Summary report: N
DUAL COOLER/HEATER
MDR report key: 2961555
·
Received February 11, 2013
Report
- Report Number
- 1828100-2013-00098
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 16, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWC
- PMA / PMN Number
- PREAMEND
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS RELATED TO MDR #1828100-2013-00099.
Description of Event or Problem · 1
THE FIELD SVC REP (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE COOLER HEATER UNIT WAS FAILING 42 DEGREE CELSIUS THERMOSTAT SHUTOFF TESTS. THE ACTUAL MEASURED TEMPERATURE WAS 43.7 DEGREE CELSIUS (THERMOSTAT CUTS OFF AT THAT POINT). SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60026 | DUAL COOLER/HEATER | COOLING AND HEATING SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 11160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |