MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-05-05 for CESAR-OMCP-VISUB (HM3000) 72239 manufactured by Philips Healthcare.
[2134858]
The equipment fails intermittently.
Patient Sequence No: 1, Text Type: D, B5
[9273172]
(b)(4). The field svc engineer (fse) was dispatched to the site and found a problem in the viewing subsystem caused by the temporal processing board (tpb) board. The fse recommended replacing this tpb board, the customer had brought the board and had the fse replace it. The system works correctly and is back in operations. No further actions required. No risk for the pt, user or bystanders.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2011-00363 |
| MDR Report Key | 2180727 |
| Report Source | 01,07 |
| Date Received | 2011-05-05 |
| Date of Report | 2011-04-14 |
| Date Mfgr Received | 2011-04-14 |
| Date Added to Maude | 2011-09-23 |
| 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 | CESAR-OMCP-VISUB (HM3000) |
| Product Code | IZF |
| Date Received | 2011-05-05 |
| Model Number | 72239 |
| 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 | 2011-05-05 |