FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON RESPONSE COAGULATION SYSTEM
MDR report key: 1624927
·
Received February 19, 2010
Report
- Report Number
- 2248721-2010-00013
- Event Type
- Malfunction
- Date Received
- February 19, 2010
- Date of Event
- January 15, 2010
- Report Date
- February 19, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- KQG
- PMA / PMN Number
- K983475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MFR METHOD: MFR EVAL OF DEVICE HISTORY RECORD COMPLETED. MFR RESULTS: MFR DHR EVALUATION DID NOT VERIFY COMPLAINT. MFR CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
HEALTH PROFESSIONAL REPORTS INCONSISTENT ACT RESULTS USING A HEMOCHRON RESPONSE SYSTEM WHILE PERFORMING A PULMONARY VEIN ISOLATION PROCEDURE. ACT RESULT 1500 USING HEMOCHRON RESPONSE SYSTEM VS ACT RESULT 381 USING A REFERENCE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON RESPONSE COAGULATION SYSTEM | HEMOCHRON RESPONSE COAGULATION ANALYZER | KQG | INTERNATIONAL TECHNIDYNE CORP. | HRS 110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |