FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 2852426
·
Received November 13, 2012
Report
- Report Number
- 1828100-2012-01438
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- October 19, 2012
- Report Date
- October 19, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT WAS CONFIRMED BY THE SVC REPAIR TECH. THE POWER SUPPLY WAS REPLACED. THE UNIT WAS TESTED TO MFR'S SPECIFICATIONS AND RETURNED TO CLINICAL USE. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem · 1
THE SERVICE REPAIR TECH REPORTED THAT DURING SAFETY TESTING OF THE DEVICE AT THE SVC CENTER, THE UNIT FAILED THE HIGH POTENTIAL TEST ON BOTH ARTERIAL AND VENOUS BLOOD PARAMETER MONITORS. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO CDI 500 BLOOD PARAMETER MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 500AVHCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |