MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-09 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..
[133973377]
Agfa healthcare (b)(4) has recently changed the company structure into two legal entities, named agfa healthcare and agfa (b)(4). This report is for agfa (b)(4) agfa (b)(4)owner operator number is (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 (b)(4) for agfa healthcare (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133973378]
On (b)(6) 2018, a customer in the us reported to agfa that when using their dx-d 100 system, they experienced unintended movement. There were three (3) events of unintended movement. Agfa is reporting each event. This mdr report is for the first event. During the first event, a tech attempted to complete a portable exam, but when the tech started to move the dx-d 100, the system took off and crashed into a chair, breaking the chair. The tech engaged the emergency stop and asked another tech to look at the system. During the second event, the second tech tried to move the dx-d 100 system, but the system once again took off and crashed into some wheelchairs. The tech engaged the emergency stop and shut the system down. The second event has been reported to fda via agfa reference number 9616389-2019-00002. During the third event, the second tech rebooted the dx-d 100 system, and tried to move the dx-d 100 again. The system again took off and ran into a wall. The tech engaged the emergency stop and did not move the system again. The third event has been reported to fda via agfa reference number 9616389-2019-00003. 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 | 9616389-2019-00001 |
| MDR Report Key | 8231163 |
| Date Received | 2019-01-09 |
| Date of Report | 2019-02-14 |
| Date of Event | 2018-12-30 |
| Date Mfgr Received | 2019-02-04 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2019-01-09 |
| 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 | 2019-01-09 |
| 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 | 2019-01-09 |