MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-09 for PHILIPS MEDIO 65 CP MEDIO 65CP-4 989000056361 manufactured by Philips Medical Systems.
[64174162]
Patient Sequence No: 1, Text Type: N, H10
[64174163]
The radiology fluoro generator stopped working during a fluoro case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6233101 |
| MDR Report Key | 6233101 |
| Date Received | 2017-01-09 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-11-11 |
| Report Date | 2016-12-15 |
| Date Reported to FDA | 2016-12-15 |
| Date Reported to Mfgr | 2016-12-15 |
| Date Added to Maude | 2017-01-09 |
| 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 | PHILIPS MEDIO 65 CP |
| Generic Name | GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC |
| Product Code | IZO |
| Date Received | 2017-01-09 |
| Model Number | MEDIO 65CP-4 |
| Catalog Number | 989000056361 |
| Device Availability | Y |
| Device Age | 23 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 595 MINER ROAD CLEVELAND OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-09 |