MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..
[144965438]
A customer in the us reported to agfa, the collimator fell from their dx-d 100 system. The customer reported when getting off the elevator the collimator assembly detached from the tube overhead of the dxd 100 system. Agfa service responded and first cleaned the area on the collimator where the tabs are located. The local agfa service engineer then drove the pins in and out to verify the function of the pins. All four pins worked and visually looked ok. The system collimator assembly was reset to the system. Agfa local service drove the unit and tested the collimator several times. With each test drive, the system tested ok. There has been no reported harm to patient or user during these events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001556265-2019-00004 |
| MDR Report Key | 8584108 |
| Date Received | 2019-05-06 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2019-05-06 |
| 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 | 2019-05-06 |
| 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, B2640 BE B2640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-06 |