MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-25 for STREAMLAB? ANALYTICAL WORKCELL manufactured by Siemens Healthcare Diagnostics Inc..
[83685146]
Details surrounding the incident are under investigation by siemens (for example, whether the cse followed instructions in service guides). As a result of the shock, the cse powered off and unplugged the automation system to perform further troubleshooting of the air compressor. On a later date, the cse installed a new air compressor. The streamlab automation system is operating according to specifications.
Patient Sequence No: 1, Text Type: N, H10
[83685147]
A siemens customer service engineer (cse) was dispatched to the customer site to perform troubleshooting on the air dryer of the streamlab automation system. The cse removed the mounting bar and received an electrical shock. The cse was not injured by the electrical shock and did not require any medical intervention or treatment. The cse powered off and unplugged the instrument to perform further troubleshooting of the air compressor due to the shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00667 |
| MDR Report Key | 6819939 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-08-25 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-07-27 |
| Date Mfgr Received | 2017-07-27 |
| Date Added to Maude | 2017-08-25 |
| 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 | ROLANDO HUALPA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242963 |
| Manufacturer G1 | INPECO S.P.A |
| Manufacturer Street | VIA GIVOLETTO 15 REGISTRATION #: 3005509212 |
| Manufacturer City | VAL DELLA TORRE (TORINO) 10040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 10040 |
| 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 | 2017-08-25 |
| 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 | 2017-08-25 |