MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-20 for FLEXLAB FLX manufactured by Inpeco Sa.
[183677127]
The procedure followed to install the hardware kit indicates first of all to "cut off energy supplies". The fse asked by email that the laboratory electrical power supply was off, but the main electrical panel was still connected to power. The fse did not checked that the circuit was dead before starting the replacement and did not cut off the automation system power supply as recommended in the procedure. The event was caused by the fse error. The hardware kit and the installation procedure were reviewed and there is no need of changes. The automation system is performing as expected. No further actions are required.
Patient Sequence No: 1, Text Type: N, H10
[183677128]
An inpeco fse received an electrical shock while he was working on the automation system, specifically his right hand touched a live 240v wire while he was replacing the circuit breaker of a distribution board of the high volume storage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010825766-2020-00002 |
| MDR Report Key | 9731889 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS EVA BALZAROTTI |
| Manufacturer Street | VIA TORRACCIA 26 |
| Manufacturer City | NOVAZZANO 6883 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6883 |
| Manufacturer G1 | INPECO SPA |
| Manufacturer Street | VIA GIVOLETTO 15 |
| Manufacturer City | VAL DELLA TORRE, 10040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 10040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXLAB |
| Generic Name | LABORATORY AUTOMATION SYSTEM |
| Product Code | CEM |
| Date Received | 2020-02-20 |
| Model Number | FLX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INPECO SA |
| Manufacturer Address | VIA TORRACCIA 26 NOVAZZANO, 6883 SZ 6883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |