MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-11-29 for INTEGRIS HM3000 72239 NA manufactured by Philips Medical Systems.
[1829385]
This x-ray system went down with pt on table.
Patient Sequence No: 1, Text Type: D, B5
[8922346]
(conclusions) - the investigation found the replacement of component, figaro ii generator control, corrected the problem. Based on trending analysis there is no exceptional replacement rate of this part. There is no required mandatory field action.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2010-00340 |
| MDR Report Key | 1942703 |
| Report Source | 07 |
| Date Received | 2010-11-29 |
| Date of Report | 2010-11-05 |
| Date of Event | 2010-11-05 |
| Date Mfgr Received | 2010-11-05 |
| Device Manufacturer Date | 2000-11-01 |
| Date Added to Maude | 2011-02-03 |
| 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 | PO BOX 10.000, VEENPLUIS 4-6 |
| Manufacturer City | BEST 5680DA |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 5680 DA |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 2010-11-29 |
| Model Number | 72239 |
| 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 | PO BOX 10.000, VEENPLUIS 4-6 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-29 |