ASSY, PRGMMED, SIU, COMP CART, NAVIO 220025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for ASSY, PRGMMED, SIU, COMP CART, NAVIO 220025 manufactured by Blue Belt Technologies.

Event Text Entries

[184427430] It was reported that during bur retract in a tka procedure, the system crashed and displayed internal cabling/drill console error, and would not start (with error 4000000000). There was also an siu fuse failure. This caused a delay of fewer than 30 minutes. The procedure was completed manually using s&n instrumentation. No other complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010266064-2020-00093
MDR Report Key9863001
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-20
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 ContactMR. RICK CONFER
Manufacturer Street2828 LIBERTY AVE SUITE 100
Manufacturer CityPITTSBURGH PA 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone4126833844
Manufacturer G1BLUE BELT TECHNOLOGIES
Manufacturer Street2905 NORTHWEST BLVD STE 40 SUITE 100
Manufacturer CityPLYMOUTH MN 55441
Manufacturer CountryUS
Manufacturer Postal Code55441
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASSY, PRGMMED, SIU, COMP CART, NAVIO
Generic NameORTHOPEDIC STEREOTAXIC INSTRUMENT
Product CodeOLO
Date Received2020-03-20
Catalog Number220025
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBLUE BELT TECHNOLOGIES
Manufacturer Address2905 NORTHWEST BLVD STE 40 PLYMOUTH MN 55441 US 55441


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-20

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