MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..
[129028159]
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 # 9616389-2018-00016 should be 10058267-2018-00001, 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
[129028160]
A customer in the us reported to agfa when using their dx-d 100 system a component fell from the system. The customer reported the locking mechanism for the tube dropped off the tube during an exam. The unit has been removed from service. Investigation is underway and a supplemental report will be provided. There has been no reported harm to patient or user during these events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616389-2018-00016 |
| MDR Report Key | 8066586 |
| Date Received | 2018-11-13 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2018-10-22 |
| Device Manufacturer Date | 2016-03-01 |
| 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, 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 | 2018-11-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGFA N.V. |
| Manufacturer Address | SEPTESTRAAT 27 MORTSEL, B2640 BE B2640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-13 |