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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); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Patient Involvement (2645)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The manufacturer representative went to the site to test the imaging system.The reported issue was confirmed and the collimator was replaced.The system was tested and it was working as intended.The rotor control box was returned to the manufacturer for evaluation.After visual/physical examination the reported issue was not confirmed.The control box was returned unused.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding an imaging system.It was reported outside of a procedure that when the manufacturer representative was uncrated this system it had an out of box failure where the collimator would not initialize.No patient was present at the time of the event.
 
Manufacturer Narrative
The collimator was returned to the manufacturer for evaluation.After visual/physical examination the reported issue was confirmed.Visual inspection confirm collimator motor wire had been displaced from the wire guide and the retraction spring of one of the motors was stretched.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.
 
Event Description
Medtronic received information regarding an imaging system.It was reported outside of a procedure that when the manufacturer representative was uncrated this system it had an out of box failure where the collimator would not initialize.No patient was present at the time of the event.
 
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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 Key8595546
MDR Text Key145146947
Report Number3006544299-2019-00089
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00763000132378
UDI-Public00763000132378
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 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
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 Manufacturer04/25/2019
Date Manufacturer Received05/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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