MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-26 for * manufactured by Siemens Healthcare Usa.
[5093412]
The pfa instrument used for closure time testing is not operational. Specimens are being sent to a sister laboratory for testing. A couple hour delay in results may be due to transport time. Every effort is being made to secure a loaner instrument but are unable to at this time. ======================manufacturer response for closure time device, (brand not provided) (per site reporter). ======================loaner became available from mfr. Obtained loaner and placed in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4172768 |
| MDR Report Key | 4172768 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-08 |
| Report Date | 2014-09-26 |
| Date Reported to FDA | 2014-09-26 |
| Date Reported to Mfgr | 2014-10-15 |
| Date Added to Maude | 2014-10-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | * |
| Generic Name | SYSTEM, AUTOMATED PLATELET AGGREGATION |
| Product Code | JOZ |
| Date Received | 2014-09-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE USA |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-26 |