MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-18 for ACCELERATOR A3600 ACP manufactured by Inpeco Sa.
[148304044]
The investigation is still ongoing to determine the root cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[148304045]
The customer contacted the service assistance for a canoe ethernet communication or can problem (software issue). The distributor fse checked the modules and found that the track corner of the automation system was not responding. He found evidence of fire on one of track corner control boards and on the cables attached to the board. The malfunction occurred during the installation of the accelerator a3600 system, so the event did not impact any patient. Nobody in the laboratory noticed smoke nor had to intervene to extinguish the possible fire. There are no reports of adverse health consequences due to the fire and the smoke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010825766-2019-00006 |
| MDR Report Key | 8707294 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-06-18 |
| Date of Report | 2019-06-18 |
| Date of Event | 2019-05-16 |
| Date Mfgr Received | 2019-05-20 |
| Date Added to Maude | 2019-06-18 |
| 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 | ACCELERATOR A3600 |
| Generic Name | LABORATORY AUTOMATION SYSTEM |
| Product Code | CEM |
| Date Received | 2019-06-18 |
| Model Number | ACP |
| 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 | 2019-06-18 |