MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-02 for CESAR-OMCP-VISUB (HM3000) 72239 manufactured by Philips Healthcare.
[1957898]
The customer reported that the screen will not boot no fluoro and there is a burning smell in the equipment room.
Patient Sequence No: 1, Text Type: D, B5
[9038714]
(b)(4). The investigation showed that the field service engineer (fse) found the geo ceaser extension board was burnt. The board was replaced and operation verified. The system's end of service was 2010. The replacement board was from the hospital stock.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2011-00090 |
| MDR Report Key | 2013415 |
| Report Source | 07 |
| Date Received | 2011-02-02 |
| Date of Report | 2011-01-05 |
| Date Mfgr Received | 2011-01-05 |
| Date Added to Maude | 2011-05-04 |
| 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 | ANTHONY PERRY |
| Manufacturer Street | 595 MINER RD |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404832025 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CESAR-OMCP-VISUB (HM3000) |
| Product Code | IZF |
| Date Received | 2011-02-02 |
| Model Number | 72239 |
| 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 HEALTHCARE |
| Manufacturer Address | VEENPLUIS 4-6 BEST 5860DA NL 5860 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-02 |