MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-15 for BVI 3000 DOME PROBE ASSY 0570-0091 manufactured by Verathon Medical.
[18251698]
It was reported that the buttons on the device did not respond, although the battery symbol was full. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[18524147]
Eval results pending analysis of the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3022472-2013-00032 |
| MDR Report Key | 2972628 |
| Report Source | 05,06 |
| Date Received | 2013-02-15 |
| Date of Report | 2013-01-18 |
| Date of Event | 2013-01-18 |
| Date Mfgr Received | 2013-01-18 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2013-04-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROD RYLANDS, VP |
| Manufacturer Street | 20001 N. CREEK PKWY |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal | 98011 |
| Manufacturer Phone | 4256295754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BVI 3000 DOME PROBE ASSY |
| Generic Name | NONE |
| Product Code | EXQ |
| Date Received | 2013-02-15 |
| Model Number | 0570-0091 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON MEDICAL |
| Manufacturer Address | BOTHELL WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-15 |