EQUIPMENT RACK 9734060 I7 110V

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for EQUIPMENT RACK 9734060 I7 110V manufactured by Medtronic Navigation, Inc.

Event Text Entries

[185500073] Concomitant medical product: product id: 9734191, serial/lot #: (b)(4). Onsite functional and visual examination was performed by a manufacturer representative. Hardware parts were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. The power supply was returned to the manufacturer for analysis. Functional testing determined that power supply outputs power as expected but the cooling fan is not working. Upon further inspection, inside the chassis the cable was pulled and caused the pins to bend allowing the connector locking tab to disengage. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185500074] Medtronic received information regarding a navigation system used during a cranial resection procedure. It was reported that prior to a case when the i7 was powered on the software displayed localizer not connected. The site rebooted the system twice with no change. The leds on the camera were green. Site continued case using axiem. There was a delay of less than 1 hour. No patient impact was correlated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01098
MDR Report Key9896916
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2012-10-11
Date Added to Maude2020-03-30
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 ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MEDTRONIC NAVIGATION, INC
Manufacturer Street826 COAL CREEK CIRCLE
Manufacturer CityLOUISVILLE CO 80027
Manufacturer CountryUS
Manufacturer Postal Code80027
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEQUIPMENT RACK 9734060 I7 110V
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-30
Returned To Mfg2020-03-26
Model Number9734060
Catalog Number9734060
Device Expiration Date2012-10-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC
Manufacturer Address826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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