MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-28 for INTEGRIS H3000 72238 NA manufactured by Philips Medical Systems.
[1814899]
This x-ray was found to have detectable ground leakage voltage.
Patient Sequence No: 1, Text Type: D, B5
[8872218]
(method, results, conclusions) - the investigation is still ongoing on this event. When the investigation is completed, a f/u report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2010-00402 |
| MDR Report Key | 1959768 |
| Report Source | 07 |
| Date Received | 2010-12-28 |
| Date of Report | 2010-12-01 |
| Date of Event | 2010-12-01 |
| Date Mfgr Received | 2010-12-01 |
| Date Added to Maude | 2011-03-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DREW QUEEN |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4254877199 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | VEENPLUIS 4-6 PO BOX 10.000 |
| Manufacturer City | BEST 5680DA |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 5680 DA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRIS H3000 |
| Generic Name | IZF (SYSTEM, X-RAY, TOMOGRAPHIC) |
| Product Code | IZF |
| Date Received | 2010-12-28 |
| Model Number | 72238 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | VEENPLUIS 4-6 PO BOX 10.000 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-28 |