MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-29 for INTEGRIS HM3000 72239 NA manufactured by Philips Medical Systems.
[1699986]
The customer reports that at the end of a patient procedure the x-ray system shut off on its own.
Patient Sequence No: 1, Text Type: D, B5
[8688979]
(eval method, results, conclusions): the investigation is still ongoing on this event. When the investigation is completed a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2010-00213 |
| MDR Report Key | 1872881 |
| Report Source | 05 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-08-23 |
| Date of Event | 2010-08-23 |
| Date Mfgr Received | 2010-08-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHAE CHANG |
| Manufacturer Street | 22100 BOTHELL EVERETT HWAY |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4259082109 |
| 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 |
| 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 | 2010-09-29 |
| 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 | PO BOX 10.000 VEENPLUIS 4-6 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-29 |