MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-23 for HEMOCHRON ACT MONITOR * manufactured by Itc.
[548532]
A 4001 model hemochron act monitor did not turn properly; inaccurate readings. Protamine required to correct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041202 |
| MDR Report Key | 787773 |
| Date Received | 2006-06-23 |
| Date of Report | 2006-06-15 |
| Date of Event | 2006-05-22 |
| Date Added to Maude | 2006-11-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON ACT MONITOR |
| Generic Name | * |
| Product Code | KQG |
| Date Received | 2006-06-23 |
| Returned To Mfg | 2006-06-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 775530 |
| Manufacturer | ITC |
| Manufacturer Address | 8 OLSEN AVENUE EDISON NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-23 |