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 |