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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

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MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM Back to Search Results
Model Number BI70002000-G30
Device Problem Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Date 09/22/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: bi71000522 lot/serial: none.A medtronic representative went to the site to perform a system checkout.The blown fuse was confirmed and the system could not power on.The fuse was replaced and discarded.The system then passed checkout.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 the system appears to have blown fuses.The mobile viewing system (mvs) power line is not illuminated.There was no patient involvement.
 
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Brand Name
O-ARM O2 IMAGING SYSTEM
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC (LITTLETON)
300 foster st
littleton MA 01460
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC (LITTLETON)
300 foster st
littleton MA 01460
Manufacturer Contact
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10593356
MDR Text Key209960964
Report Number3004785967-2020-01126
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/28/2020
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-G30
Device Catalogue NumberBI70002000-G30
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2020
Initial Date FDA Received09/28/2020
Was Device Evaluated by Manufacturer? Yes
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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