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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 Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2023
Event Type  malfunction  
Event Description
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that there was a burning smell coming from the system when it was plugged in and turned on. there was no patient involvement.
 
Manufacturer Narrative
Continuation of d10: section d references the main component of the system.Other medical products in use during the event include: product id:  bi71000860, lot no.Unknown; product id:  bi71000163, lot no.Unknown , h6: the system was serviced in the field and there was a burning smell coming from the generator and the image acquisition system (ias) didn't boot.Troubleshot and found that the power conversion enclosure was not supplying the 12vdc output to the ias pc and ethernet switch.Removed exterior cover and found physical damage to the pce board.Replaced the damaged pce, installed firmware, and performed a system checkout.The system was now fully functional and passed a system checkout.B01, c02, c07, and d02 are applicable.  medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
H3, h6: product bi71000860r was received for analysis.Confirm reported complaint, "burning smell." visual inspections shows components l33 and c125 are electrically over stressed.Faulty power conversion enclosure.Previously reported b01, c02, and d02 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Lot number updated for product in d10.Continuation of d10: product id: bi71000860r, lot number: 2022323004 rev.A medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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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 Key18012036
MDR Text Key326622046
Report Number3006544299-2023-00708
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00763000068097
UDI-Public00763000068097
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/14/2023
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? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/23/2023
Initial Date FDA Received10/26/2023
Supplement Dates Manufacturer Received11/09/2023
11/09/2023
Supplement Dates FDA Received11/14/2023
11/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2018
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 H10...; SEE H10...
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