MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for MOBILE DIAGNOSTIC WDR 9890-010-89522 manufactured by Philips Medical Systems, Inc..
[130048966]
Back up on portable x-ray machine malfunctioned and would not turn off. Potential to injure staff or patients if they were hit by this device. Per manufacturer response to the hospital, dmc board replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8154632 |
| MDR Report Key | 8154632 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-11-26 |
| Report Date | 2018-12-06 |
| Date Reported to FDA | 2018-12-06 |
| Date Reported to Mfgr | 2018-12-12 |
| Date Added to Maude | 2018-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILE DIAGNOSTIC WDR |
| Generic Name | X-RAY, MACHINE, PORTABLE |
| Product Code | IZL |
| Date Received | 2018-12-12 |
| Model Number | 9890-010-89522 |
| Catalog Number | 9890-010-89522 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |