BENCHMARK ULTRA 750-600 05342716001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for BENCHMARK ULTRA 750-600 05342716001 manufactured by Ventana Medical Systems.

Event Text Entries

[142234405] No reported injury: mdr reported for same failure more reported in mdr-2028492-2016-00004-00.
Patient Sequence No: 1, Text Type: N, H10


[142234406] Instrument malfunction: tub overflow occurred and allowed fluid to reach floor. Tub sensor(s) did not properly report error and prevent fluid leak. The following failure mode is same event reported in mdr-2028492-2016-00004-00 which caused serious slip and fall injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028492-2019-00006
MDR Report Key8506106
Date Received2019-04-11
Date of Report2019-04-11
Date of Event2019-03-14
Date Mfgr Received2019-03-14
Date Added to Maude2019-04-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA TIM GIBLIN
Manufacturer Street1910 E INNOVATION PARK DRIVE NA
Manufacturer CityTUSCON AZ 85755
Manufacturer CountryUS
Manufacturer Postal85755
Manufacturer Phone5208777035
Single Use3
Remedial ActionRP
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameBENCHMARK ULTRA
Generic NameBENCHMARK ULTRA
Product CodeKPA
Date Received2019-04-11
Model Number750-600
Catalog Number05342716001
Lot Number314645
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVENTANA MEDICAL SYSTEMS
Manufacturer Address1910 E. INNOVATION PARK DR. NA TUCSON AZ 857551962 US 857551962


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-11

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