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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

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SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number BI70002000
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
Event Type  Injury  
Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m021083c001, software version #: 4.2.1.H3, h6: the system was serviced in the field by a medtronic representative.The rep ran rad/gain calibration and extended rad/gain calibration separately while rebooting in between attempts.Verified 20 and 40cm fov spins appeared normal.The rep enabled 2dlf feature and completed long film gain calibrations.The rep trained the radiologic technologist to perform rad/gain calibrations individually.Codes b01, c13, and d02 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that after acquiring a 3d spin, all planes appeared entirely black.The 3d spin automatically transferred to the navigation system, and all planes but sagittal appeared entirely black, as well.The sagittal plane appeared entirely white.The same issue occurred with the next 2 scans.The 2d scout shots appeared as expected.Troubleshooting was performed.Multiple reboots were attempted, with no effect.The local representative (rep) was unable to change brightness and contrast on the navigation system.The level and width buttons appeared and could be pressed but the appearance of the images was unchanged.There were no error messages that appeared during any of the scans.All scans were 40 cm fov.On the mobile viewing station (mvs), the rep attempted again to change the brightness and contrast.Holding brightness for a long period of time resulted in all 3 planes appearing entirely white.The rep confirmed that no constructs were present in the patient's anatomy.It was confirmed that there was nothing in the gantry aside from the pat ient and reference frame. the procedure was aborted.There was no reported delay prior to aborting the procedure.There was no reported impact to the patient.
 
Event Description
Additional information was received.It was reported that the procedure was aborted after anesthesia had been administered and an incision had been made.Another procedure will need to be scheduled to complete treatment.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Manufacturer Narrative
H3, h6: software analysis was completed.There was enough evidence to say that a software anomaly occurred.Codes b01, c10, and d18 apply.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
O-ARM O2 IMAGING SYSTEM
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
SANMINA -SCI SYSTEMS
km 15.5 no. 29, plant 06
carr. chapala-guadalajara,jal 45640
MX  45640
Manufacturer (Section G)
SANMINA -SCI SYSTEMS
km 15.5 no. 29, plant 06
carr. chapala-guadalajara,jal 45640
MX   45640
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key18980708
MDR Text Key339337371
Report Number3006544299-2024-00241
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00763000616564
UDI-Public00763000616564
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBI70002000
Device Catalogue NumberBI70002000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2024
Initial Date FDA Received03/26/2024
Supplement Dates Manufacturer Received03/26/2024
Supplement Dates FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
SEE H11...
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age81 YR
Patient SexFemale
Patient Weight100 KG
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