BVI 3000 DOME PROBE ASSY 0570-0091

MAUDE Adverse Event Report

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 Verathno Medical.

Event Text Entries

[3330269] It was reported that the device was reading inaccurately. This issue occurred on multiple pts and by multiple users. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5

[10568244] The reported incident was not confirmed. The system operated as intended.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3022472-2013-00052
• MDR Report Key: 2972537
• 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: 2011-11-01
• 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 NORTH CREEK PARKWAY
• 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

Device Details

• Brand Name: BVI 3000 DOME PROBE ASSY
• Generic Name: NONE
• Product Code: EXQ
• Date Received: 2013-02-15
• Returned To Mfg: 2013-01-24
• Model Number: 0570-0091
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VERATHNO MEDICAL
• Manufacturer Address: BOTHELL WA US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-02-15