MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-03 for STREAMLAB? ANALYTICAL WORKCELL manufactured by Siemens Healthcare Diagnostics Inc.
[92058908]
The customer contacted the siemens customer care center (ccc) to report the smoke. A siemens customer service engineer (cse) was dispatched to the customer site. Service was performed over multiple visits. The cse tested the centrifuge functionality and it was proper. The cse inspected the centrifuge module and had issues with centrifuge robot rotational. The cse replaced the rotational and vertical stepper boards. The cse installed stepper driver boards. The cse replaced stepper driver boards for centrifuge robots y and z. The cse verified operation of centrifuge robot, which was acceptable. The cse found condensation inside airlines and air compressor running nonstop. The cse replaced start up and unloader valves on air compressor and water trap on incoming airline. The cse tested streamlab in diagnostics, which passed. The cse watched streamlab process samples. The cause of the smoke is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[92058909]
Smoke was emitted from a streamlab core unit centrifuge. The centrifuge was powered off. There are no reports of patient intervention or adverse events due the smoke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00802 |
| MDR Report Key | 7000750 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-03 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-10-10 |
| Date Added to Maude | 2017-11-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | INPECO S.P.A |
| Manufacturer Street | VIA GIVOLETTO 15 REGISTRATION# 3005509212 |
| Manufacturer City | 10040 VAL DELLA TORRE (TORINO), |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STREAMLAB? ANALYTICAL WORKCELL |
| Generic Name | STREAMLAB? ANALYTICAL WORKCELL |
| Product Code | LGX |
| Date Received | 2017-11-03 |
| Model Number | STREAMLAB? ANALYTICAL WORKCELL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-03 |