MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for STRATUS CS 10453531 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[41172927]
Siemens customer service engineer (cse) inspected the analyzer and found lamp connector melted into lamp manager. He replaced defective lamp and lamp manager. Cse calibrated standard tab, performed alignments and ran system check, everything was working as intended. Customer ran qc and it was running ok. Instrument is fully operational.
Patient Sequence No: 1, Text Type: N, H10
[41172928]
Customer observed smoke coming out of the stratus chassis when running a blood sample hence turned off the stratus power. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2016-00033 |
| MDR Report Key | 5516238 |
| Date Received | 2016-03-22 |
| Date of Report | 2016-03-22 |
| Date of Event | 2016-02-24 |
| Date Mfgr Received | 2016-02-24 |
| Date Added to Maude | 2016-03-22 |
| 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 | 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 | 0 |
| Brand Name | STRATUS CS |
| Generic Name | STRATUS CS |
| Product Code | DAP |
| Date Received | 2016-03-22 |
| Catalog Number | 10453531 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-03-22 |