MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for PHILIPS MOBILEDIAGNOST WDR manufactured by Sedecal Sa.
[125295836]
This is a mobile diagnostic x-ray unit. The collimator on the unit was serviced. As a result of improper re-attachment, the collimator fell off the tube-head during subsequent use. It was then left dangling by its cable. No one was injured. A service person subsequently re-attached the collimator in a proper fashion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617251-2018-00002 |
| MDR Report Key | 7984277 |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-10-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARIA GOMEZ |
| Manufacturer Street | PELAYA, 9 . POL. IND. RIO DE JANEIRO |
| Manufacturer City | ALGETE, MADRID 28110 |
| Manufacturer Country | SP |
| Manufacturer Postal | 28110 |
| Manufacturer G1 | SEDECAL SA |
| Manufacturer Street | PELAYA 9 POL. IND. "RIO DE JANEIRO" |
| Manufacturer City | ALGETE, MADRID 28110 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHILIPS |
| Generic Name | MOBILE DIAGNOSTIC X-RAY SYSTEM |
| Product Code | IZL |
| Date Received | 2018-10-19 |
| Model Number | MOBILEDIAGNOST WDR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEDECAL SA |
| Manufacturer Address | PELAYA, 9 . POL. IND. RIO DE JANEIRO ALGETE,, MADRID 28110, SP 28110, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-19 |