MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-08 for PACSCUBE manufactured by Datcard Systems, Inc..
[86008519]
Patient Sequence No: 1, Text Type: N, H10
[86008520]
Customer reported that unit had smell of burning plastic. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003341080-2017-00002 |
| MDR Report Key | 6853934 |
| Date Received | 2017-09-08 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-08-25 |
| Date Added to Maude | 2017-09-08 |
| 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 | MEDICAL IMAGE COMMUNICATIONS DEVICE |
| Product Code | LMD |
| Date Received | 2017-09-08 |
| Returned To Mfg | 2017-09-06 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-08 |