MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-19 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS 110 manufactured by International Technidyne Corp..
[1333835]
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.
Patient Sequence No: 1, Text Type: D, B5
[8521979]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2010-00013 |
| MDR Report Key | 1624927 |
| Report Source | 05,06 |
| Date Received | 2010-02-19 |
| Date of Report | 2010-02-19 |
| Date of Event | 2010-01-15 |
| Date Mfgr Received | 2010-01-19 |
| Date Added to Maude | 2010-08-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE PICCIANO |
| Manufacturer Street | 6-8 OLSEN AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 7325485700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON RESPONSE COAGULATION SYSTEM |
| Generic Name | HEMOCHRON RESPONSE COAGULATION ANALYZER |
| Product Code | KQG |
| Date Received | 2010-02-19 |
| Returned To Mfg | 2010-01-26 |
| Model Number | HRS 110 |
| Catalog Number | HRS 110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-02-19 |