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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number BI70002000
Medical Device Problem Code Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/17/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: kit svc o2 (b)(4) power supply psi, lot/serial: unknown.A medtronic representative went to the site to perform a system checkout.The power supply was found to have 0 vdc output.The power supply was replaced and the system passed checkout.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding an imaging system.It was reported outside of a procedure that while being used for medtronic demonstrations, the system's generator was not initializing.There was no patient involvement.
 
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Brand Name
O-ARM O2 IMAGING SYSTEM
Common Device Name
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC (LITTLETON)
300 foster st
littleton MA 01460
MDR Report Key10960803
Report Number3004785967-2020-01472
Device Sequence Number10908492
Product Code OWB
UDI-Device Identifier00643169980976
UDI-Public00643169980976
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K200074
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/07/2020
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
Operator of Device Health Professional
Device Model NumberBI70002000
Device Catalogue NumberBI70002000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/17/2020
Initial Report FDA Received Date12/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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