MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-18 for CESAR-OMCP-VISUB (HM3000) 72239 manufactured by Philips Healthcare.
[1711260]
It was reported that the equipment turned off during the examination.
Patient Sequence No: 1, Text Type: D, B5
[9100665]
(b)(4). The investigation is still ongoing on this event. When investigation is completed, a follow-up report will be sent to the fda by (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2011-00018 |
| MDR Report Key | 1995594 |
| Report Source | 07 |
| Date Received | 2011-01-18 |
| Date of Report | 2010-12-20 |
| Date Mfgr Received | 2010-12-20 |
| 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 | CHRISTINE BERARD |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786593099 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CESAR-OMCP-VISUB (HM3000) |
| Product Code | IZF |
| Date Received | 2011-01-18 |
| 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 | 2011-01-18 |