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 Verathon Medical.

Event Text Entries

[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


MAUDE Entry Details

Report Number3022472-2013-00032
MDR Report Key2972628
Report Source05,06
Date Received2013-02-15
Date of Report2013-01-18
Date of Event2013-01-18
Date Mfgr Received2013-01-18
Device Manufacturer Date2007-12-01
Date Added to Maude2013-04-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactROD RYLANDS, VP
Manufacturer Street20001 N. CREEK PKWY
Manufacturer CityBOTHELL WA 98011
Manufacturer CountryUS
Manufacturer Postal98011
Manufacturer Phone4256295754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBVI 3000 DOME PROBE ASSY
Generic NameNONE
Product CodeEXQ
Date Received2013-02-15
Model Number0570-0091
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVERATHON MEDICAL
Manufacturer AddressBOTHELL WA US


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-15

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