MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-23 for ACCELERATOR A3600 ACP manufactured by Inpeco Sa.
[142805175]
The distributor reported the wire 207 was not securely fastened into relay 2ka1. The loose wire connection caused a short circuit. The 207 wire conducts 24v. The event caused the damage of the 620840010. 0 cable and melted parts of the wire tray. The electrical panel is located inside the aliquoter module behind the protective covers. Usually users cannot come in direct contact with the impacted component. In this case the event occured during the module installation so the cover was not in position yet. Only trained service personnel was working on the module. Due to the relay 2ka1 malfunction, the aliquoter module pc was not powered. All the electrical components included in the accelerator a3600 automation system are tested for flame retardancy and they have a flammability rating at least v-2: in case of fire the electric parts are auto extinguishing in 10-30 seconds without any intervention of the laboratory personnel. The issue was fixed replacing the damaged cable and the relay. The instrument is now performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[142805176]
The customer reported a malfunction of the aliquoter module included in the accelerator a3600 automation system due to a short circuit inside the module electrical panel. The small electrical fire caused by the short circuit auto-extinguished without the intervention of any laboratory technicians. There are no reports of adverse health consequences due to the fire and the possible smoke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010825766-2019-00004 |
| MDR Report Key | 8539414 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Remedial Action | OT |
| 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 | 2019-04-23 |
| Model Number | ACP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-04-23 |