MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-25 for POLY C-OMCP-VISUB (H3000) 72238 manufactured by Philips Healthcare.
[1713242]
The customer reported the system displayed an error indicating x-ray generator is not available.
Patient Sequence No: 1, Text Type: D, B5
[9101146]
(b)(4). The investigation revealed that the x-ray tube failed and was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2011-00043 |
| MDR Report Key | 1996134 |
| Report Source | 07 |
| Date Received | 2011-01-25 |
| Date of Report | 2010-12-27 |
| Date Mfgr Received | 2010-12-27 |
| Date Added to Maude | 2011-03-14 |
| 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 | ANTHONY PERRY |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404832025 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLY C-OMCP-VISUB (H3000) |
| Product Code | IZF |
| Date Received | 2011-01-25 |
| Model Number | 72238 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | VEENPLUIS 4-6 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-25 |