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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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2022
Event Type  malfunction  
Event Description
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the gantry of the imaging system could be moved by the facility after applying minimal force.There was no patient present when this issue was identified.
 
Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.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 Key14572853
MDR Text Key293144936
Report Number3006544299-2022-00193
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K200074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
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
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/11/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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