O-ARM O2 IMAGING SYSTEM BI70002000

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 2020-03-23 for O-ARM O2 IMAGING SYSTEM BI70002000 manufactured by Sanmina -sci Systems.

Event Text Entries

[185002056] Other relevant device(s) are: product id: bi-500-01065 o-arm software - o2, (b)(4), serial/lot : n/a. A medtronic representative went to the site to perform a system check out and the system performed as intended. The system passed all tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185002057] Medtronic received information regarding an imaging system being used during a spinal procedure. It was reported that the technician was holding the button on the remote to conduct the spin, while the manufacturer representative was exiting the room. The representative peaked through the window to verify that the navigation system was seeing the reference frame and the imaging system, but it was found that the navigation system was no longer seeing the imaging system in the camera view. The representative immediately walked back into the room and saw that the mobile viewing station (mvs) was still on, but the pendant on the image acquisition system(ias) was not lit up, which means it was off. The representative pushed the power button and the imaging system powered up right away. The imaging system completed the startup, initialization, and then the surgical team proceeded with the scan. A confirmation scan was performed a few hours later with no issues. There was no patient harm and the procedure was delayed by five minutes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006544299-2020-00095
MDR Report Key9864832
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2020-01-12
Date Added to Maude2020-03-23
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 G1SANMINA -SCI SYSTEMS
Manufacturer StreetKM 15.5 NO. 29, PLANT 06
Manufacturer CityCARR. CHAPALA-GUADALAJARA,JAL 45640
Manufacturer CountryMX
Manufacturer Postal Code45640
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameO-ARM O2 IMAGING SYSTEM
Generic NameINTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Product CodeOWB
Date Received2020-03-23
Model NumberBI70002000
Catalog NumberBI70002000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSANMINA -SCI SYSTEMS
Manufacturer AddressKM 15.5 NO. 29, PLANT 06 CARR. CHAPALA-GUADALAJARA,JAL 45640 MX 45640


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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