MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-22 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..
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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). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
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On january 7, 2019, a customer in (b)(6) reported to agfa that when using their dx-d 100 system, they experienced unintended movement. The customer reported the dx-d 100 system was moved into position to take an image when the unit made a long beeping sound and then started to move forward with no one touching the handle. The dx-d 100 hit a wall but was still trying to go forward. The system stopped when the emergency stop button was pressed. Investigation is under way 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 | 9616389-2019-00005 |
| MDR Report Key | 8266697 |
| Date Received | 2019-01-22 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-01-22 |
| 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 | 2019-01-22 |
| 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 | 2019-01-22 |