MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..
[139422027]
A customer in (b)(6) reported to agfa an event of unintended movement of their dx-d 100 system. The customer reported the user was moving the dx d 100 and then the dx d 100 system increased speed abnormally and generated a beep signal. The user only could stop the system pressing the red emergency button. 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 | 3001556265-2019-00002 |
| MDR Report Key | 8433682 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-06-17 |
| Date of Event | 2019-03-02 |
| Date Mfgr Received | 2019-06-14 |
| Date Added to Maude | 2019-03-19 |
| 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 |
| 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 | 2019-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-19 |