MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-25 for PACSCUBE manufactured by Datcard Systems, Inc.
[44364952]
Customer plugged monitor and pc into the power supply, then plugged power supply into power outlet. When he pushed the power button on the power supply, it sparked and began to flame.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003341080-2016-00001 |
| MDR Report Key | 5605403 |
| Date Received | 2016-04-25 |
| Date of Event | 2016-04-21 |
| Date Mfgr Received | 2016-04-21 |
| Date Added to Maude | 2016-04-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 7 GOODYEAR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9499321300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PACSCUBE |
| Generic Name | DIGITAL IMAGE COMMUNICATIONS DEVICE |
| Product Code | LMD |
| Date Received | 2016-04-25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATCARD SYSTEMS, INC |
| Manufacturer Address | 7 GOODYEAR IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-25 |