MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for DX-D600 - DXD IMAGING PACKAGE manufactured by Agfa N.v..
[129028379]
Due to recent changes, agfa (b)(4) is now separate from agfa healthcare (b)(4). Agfa (b)(4) is currently awaiting the assignment of a fda registration number. This report has been submitted via the manufacturer registration number 9616389 for agfa healtcare (b)(4). For this report, the mfr report # 9616389-2018-00017 should be 10058267-2018-00002, however due to technical restraints of the esubmitter system, the agfa (b)(4) owner/operator number could not be entered into the mfr report # field.
Patient Sequence No: 1, Text Type: N, H10
[129028380]
A customer in the us reported to agfa when using their dx-d 600 system, the tube was moving at an abnormal speed. The customer reported the tube was moving around the room quickly and not lining up with the board. During the investigation by agfa, agfa service confirmed the system was moving at an abnormal speed in the transversal direction. Agfa service replaced the tachometer, which controls the speed of the unit the transversal direction. Agfa service tested the unit and auto centered the unit three times to the wall and table with normal transversal speed movement. The unit is now working as intended. There has been no reported harm to patient or user during these events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616389-2018-00017 |
| MDR Report Key | 8066807 |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2018-11-13 |
| 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 N.V. |
| Manufacturer Street | SEPTESTRAAT 27 |
| Manufacturer City | MORTSEL, B 2640 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | B 2640 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DX-D600 - DXD IMAGING PACKAGE |
| Generic Name | DX-D 600 SYSTEM |
| Product Code | KPR |
| Date Received | 2018-11-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGFA N.V. |
| Manufacturer Address | SEPTESTRAAT 27 MORTSEL, B 2640 BE B 2640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-13 |