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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 Problems Arcing (2583); Unexpected Shutdown (4019); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative visited the site to checkout the system.They were not able to replicate the complaint through testing.There was no confirmed sparking, but generator errors 66 and 139 were seen in the logs.Oil tanks were low, but refilled and silicon wafers replaced.System tested thoroughly in 2d and 3d modes without any issues.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from a manufacturer representative regarding an imaging system outside of a procedure during calibration.It was reported that while taking the 3rd spin in their tracker calibration the system shut down unexpectedly accompanied by a popping noise.They power cycled both the mvs and ias and the pendant showed x-ray disabled.They rebooted both the ias and mvs again and were able to get the pendant in a state where they could take another spin.They reported that the system sparked during that spin and the ias went into an initializing state.They aborted the calibration.
 
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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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key11016513
MDR Text Key223620423
Report Number3006544299-2020-00489
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00763000355555
UDI-Public00763000355555
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/15/2020
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
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2020
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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