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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS O2; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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SANMINA -SCI SYSTEMS O2; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number BI70002000
Device Problems Device Damaged Prior to Use (2284); Positioning Problem (3009); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Patient Involvement (2645)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that due to collimator error no x-rays possible and that source is not homing anymore.Source drive to be replaced and source drive assembly replaced and aligned.System functions tested.The imaging system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from a manufacturer representative (rep) regarding an imaging system outside of a procedure.The rep indicated that during the startup test the source homing was not successful.The system "stuck's at this step and states error at collimator initialization".The issue was detected at "physicist testing" and the system was not in clinical use.It was also noted that the source drive was not homing.No patient was involved with this issue.
 
Manufacturer Narrative
The source drive assembly was returned to the manufacturer for evaluation.Testing found that the internal signal wires on the unit were shorted as the unit failed motor isolation testing.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
O2
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
MDR Report Key8424893
MDR Text Key139059829
Report Number3006544299-2019-00046
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00763000074050
UDI-Public00763000074050
Combination Product (y/n)N
PMA/PMN Number
K151000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
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
Date Returned to Manufacturer04/16/2019
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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