FDA Adverse Event
Malfunction
Summary report: N
DUAL COOLER/HEATER
MDR report key: 3162422
·
Received June 6, 2013
Report
- Report Number
- 1828100-2013-00549
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 16, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWC
- PMA / PMN Number
- PREAMEND
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THIS COMPLAINT IS RELATED TO MDR #1828100-2013-00535.
Description of Event or Problem · 1
THE FIELD SERVICE REP (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE COOLER HEATER UNIT WAS NOT HEATING. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251634 | DUAL COOLER/HEATER | COOLING & HEATING SYSTEM | DWC | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 11160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |