MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-28 for PACSCUBE manufactured by Datcard Systems, Inc.
[27102251]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27102252]
Initial complaint from customer was "unable to import". Upon further troubleshooting with customer, when they import multiple studies, some studies may be sent with non-updated data. This can result in studies being attached to incorrect patients due to matching accession numbers. Either a software malfunction or a user error; tech support and software qa unable to duplicate reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003341080-2015-00001 |
| MDR Report Key | 5107971 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-28 |
| Date Mfgr Received | 2015-09-10 |
| Date Added to Maude | 2015-09-28 |
| 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 | 3 |
| Brand Name | PACSCUBE |
| Generic Name | DIGITAL IMAGE COMMUNICATIONS DEVICE |
| Product Code | LMD |
| Date Received | 2015-09-28 |
| Device Availability | Y |
| 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 | 2015-09-28 |