MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2009-09-10 for HEMOCHRON RESPONSE 220V SYSTEM manufactured by International Technidyne Corp..
[1539076]
Hemochron response system is not detecting end point and continues to run until time limit of 1500 seconds. Therapeutic range not reported. No report of adverse event, serious injury, or interventions.
Patient Sequence No: 1, Text Type: D, B5
[8655030]
(b)(4). This mdr is submitted based upon a retrospective review of complaint reports from 2007-2008 in light of revised itc md evaluation procedures. Manufacturer method: no product returned from user facility. Manufacturer results: customer complaint could not be confirmed. Manufacturer conclusions: no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2009-00484 |
| MDR Report Key | 1711972 |
| Report Source | 01,05,08 |
| Date Received | 2009-09-10 |
| Date of Report | 2009-08-26 |
| Date of Event | 2008-03-12 |
| Date Mfgr Received | 2007-08-09 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2010-10-01 |
| 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 | 0 |
| 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 RESPONSE 220V SYSTEM |
| Generic Name | RESPONSE INSTRUMENT |
| Product Code | KQG |
| Date Received | 2009-09-10 |
| Model Number | RESPONSE |
| Catalog Number | RESPONSE |
| Lot Number | UNK |
| 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 |