MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-30 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..
[144965572]
A customer in the us reported to agfa an event of unintended movement of their dx-d 100 system. The customer reported the dx-d 100 system continued to start and stop in different ways on its own and eventually hit a wall putting a hole into the wall. The unit was removed from service. Agfa onsite service investigation revealed there was a lack of subcontractor service maintenance and routine checking the cleanliness of the system, resulting in dust and debris accumulation on the system's chains, wheels, and inner dmc board which contributed to the unintended movement. The entire system was cleaned, including sprockets and chains. Maintenance checks were performed with corrections to switch settings, voltage adjustments, chain tensions, and dmc board and strain gauge replacements. The system was re-assembled and fully tested. The unit drove much smoother with no more noises from the drive system. The system now turns well with a stopping distance from full speed to about 2 feet. The system's reverse drive is straight and working correctly. The system was placed back into customer use with no further issues. There has been no reported harm to patient or user during these events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001556265-2019-00003 |
| MDR Report Key | 8566115 |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-04-30 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 2019-04-30 |
| 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 | 2019-04-30 |