MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-08 for INTEGRIS HM3000 72239 NA manufactured by Philips Medical Systems.
[1744411]
The site reported an elevated fluoro dose from this x-ray system.
Patient Sequence No: 1, Text Type: D, B5
[8929879]
Eval 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 | 3003768277-2010-00356 |
MDR Report Key | 1942667 |
Report Source | 07 |
Date Received | 2010-12-08 |
Date of Report | 2010-08-10 |
Date of Event | 2010-08-10 |
Date Mfgr Received | 2010-08-10 |
Device Manufacturer Date | 1999-11-23 |
Date Added to Maude | 2011-03-02 |
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 HM3000 |
Generic Name | IZF (SYSTEM, X-RAY, TOMOGRAPHIC) |
Product Code | IZF |
Date Received | 2010-12-08 |
Model Number | 72239 |
Catalog Number | NA |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
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 | 2010-12-08 |