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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 03/14/2024
Event Type  malfunction  
Manufacturer Narrative
H6: the system was serviced in the field and there were double rings on phantom.The manufacturer representative (rep) performed rad gain calibration and a 3d image quality test.  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 there were poor quality images after taking a 3d spin.The images are very grainy and blurred.Multiple spins awere done and the issue was unresolved.There was no impact on patient outcome.Delay in surgery was not provided.
 
Event Description
Additional information was received.There was a delay in surgery.It was the time it took to do a secondary spin to confirm image quality.
 
Manufacturer Narrative
H6: additional annex f code added.Additional information added to sections a and b5.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
Additional information was received.It was reported that there was a surgical delay of 15-20 minutes.
 
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.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
8200 coral sea st ne
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key18934123
MDR Text Key338318346
Report Number3006544299-2024-00215
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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 03/14/2024
Initial Date FDA Received03/19/2024
Supplement Dates Manufacturer Received04/17/2024
Supplement Dates FDA Received05/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age18 YR
Patient SexMale
Patient Weight31 KG
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