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 2017-01-06 for SYNGO LAB DATA MANAGER APPLICATION SOFTWARE manufactured by Siemens Healthcare Diagnostics Inc.
[64061260]
The customer contacted a siemens customer care center (ccc). Ccc specialist instructed the customer to unplug the cpu computer from the uninterrupted power supply unit. A siemens field service engineer (fse) was dispatched to the customer site. The fse found that the computer's main board was damaged, due to a short. The fse installed a new syngo cpu computer. The cause of smoke emitted from the syngo cpu computer was due a main board short. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[64061261]
The customer reported smoke was emitted from syngo lab data manager central processing unit (cpu) computer. The customer's facility department removed the cpu from their laboratory. There were no reports of injury to staff, damage to property, or impact to patient samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00023 |
| MDR Report Key | 6229207 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-06 |
| Date of Report | 2016-01-06 |
| Date of Event | 2016-12-14 |
| Date Mfgr Received | 2016-12-14 |
| Date Added to Maude | 2017-01-06 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION NUMBER: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNGO LAB DATA MANAGER APPLICATION SOFTWARE |
| Generic Name | SYNGO LAB DATA MANAGER APPLICATION SOFTWARE |
| Product Code | NSX |
| Date Received | 2017-01-06 |
| Model Number | SYNGO LAB DATA MANAGER APPLICATION SOFTWARE |
| 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 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-06 |