MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-11-17 for INTEGRIS H3000 72238 NA manufactured by Philips Medical Systems.
[1677440]
The customer reported that this x-ray system stopped during an examination with a pt on the table. The system would not restart.
Patient Sequence No: 1, Text Type: D, B5
[8905147]
(conclusions) - method and results (other) - this system problem was solved by replacing several hardware components. The exact root cause is unk. The system was repaired by the replacement of several hardware components which might have contributed to the reported problem. None of these components have exceptional or increased failure rates. The failure rates are monitored for these components. Therefore, risk to pt remains acceptable. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2010-00310 |
| MDR Report Key | 1912519 |
| Report Source | 07 |
| Date Received | 2010-11-17 |
| Date of Report | 2010-10-21 |
| Date of Event | 2010-10-21 |
| Date Mfgr Received | 2010-10-21 |
| Date Added to Maude | 2011-03-07 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRIS H3000 |
| Generic Name | IZF (SYSTEM, XRAY, TOMOGRAPHIC) |
| Product Code | IZF |
| Date Received | 2010-11-17 |
| 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 | PO BOX 10.000 VEENPLUIS 4-6 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-17 |