MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa Healthcare N.v..
[124973133]
A customer in the us reported to agfa when using their dx-d 100 system the unit moved on its own. It was reported the system would drive forward and to the side. The customer hit the emergency stop to shut down the system. Agfa service completed an investigation of the system. All components related to the driving of the system were checked and no issues were found. The system is now operating as intended with no additional issues reported. There has been no reported harm to patient or user during these events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616389-2018-00015 |
| MDR Report Key | 7985416 |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-10-11 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2018-10-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. CASSANDRA MCGOWAN |
| Manufacturer Street | 10 S ACADEMY STREET |
| Manufacturer City | GREENVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211984 |
| Manufacturer G1 | AGFA HEALTHCARE N.V. |
| Manufacturer Street | SEPTESTRAAT 27 |
| Manufacturer City | MORTSEL, B2640 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | B2640 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 |
| Generic Name | DX-D 100 MOBILE |
| Product Code | IZL |
| Date Received | 2018-10-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGFA HEALTHCARE N.V. |
| Manufacturer Address | SEPTESTRAAT 27 MORTSEL, B2640 BE B2640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-19 |