MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-20 for STRATUS CS 10444834 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[43996621]
Customer has been asked to provide message logs and extended calibrations print out to evaluate the event. The root cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[43996622]
Customer reported discrepancy between troponin results on stratus cs analyzer. There was no report of injury due to the event.
Patient Sequence No: 1, Text Type: D, B5
[46482870]
Siemens field service engineer reviewed and evaluated customer provided print outs. There were no irregularities identified. Customer has not had any further issues with the instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00043 |
| MDR Report Key | 5591113 |
| Date Received | 2016-04-20 |
| Date of Report | 2016-05-19 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-04-20 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY |
| Manufacturer City | NEWARK DE 19702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATUS CS |
| Generic Name | STRATUS CS |
| Product Code | DAP |
| Date Received | 2016-04-20 |
| Catalog Number | 10444834 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-20 |