MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-10 for HEMOCHRON SYSTEM HRS. 110 manufactured by International Technidyne Corp..
[18914193]
Test aborted at 360 seconds post cardiac catheterization using hemochron response / celite system. Subsequently 153 second (expected) result with 2nd response instrument ((b)(4)). Therapeutic range and pt baseline not reported. No report of adverse event, serious injury, or intervention.
Patient Sequence No: 1, Text Type: D, B5
[18989177]
(b)(4). Customer reported evals: lqc performed with acceptable results. Eqc performed with acceptable results. Mfr eval / investigation pending additional info from consumer. Method, results, conclusions: mfr eval / investigation pending additional info from consumer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2009-00493 |
| MDR Report Key | 1712000 |
| Report Source | 05 |
| Date Received | 2009-09-10 |
| Date of Report | 2009-08-27 |
| Date of Event | 2008-06-19 |
| Date Mfgr Received | 2009-07-21 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2010-08-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID GRONOSTAJSKI |
| Manufacturer Street | 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 SYSTEM |
| Generic Name | RESPONSE INST / FTCA510 CELITE TUBE |
| Product Code | KQG |
| Date Received | 2009-09-10 |
| Model Number | HRS. 110 |
| Catalog Number | HRS. 110 |
| Lot Number | E7FTE137B |
| Device Expiration Date | 2010-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2009-09-10 |