MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00027-120

Device Problems Device Emits Odor (1425); Low Battery (2584)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

A site representative reported that the imaging system had a critical battery error.The site representative reported smelling a burnt electronic odor while evaluating the system.There was no patient present when this issue was identified.

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative, following up with the site, tested the system and found internal motion batteries that leaked and shorted against the battery bracket.Replacement batteries and battery charger board shipped to site for issue resolution.On 16-apr-2015, a medtronic representative replaced batteries and battery charger board and performed a imaging system check-out, all areas passed.Medtronic investigation of returned suspect device confirmed the reported issue.A visual inspection of the batteries found one battery damaged due to electrical over-stress and one battery exhibits corrosion.All other batteries showed normal signs of usage.An electrical voltage testing of the batteries found the over-stressed battery measured 10.38 vdc, the remaining batteries measured at 13 vdc as expected.The reported event was confirmed to be caused by an electrical failure mode of the batteries.

Manufacturer Narrative

Medtronic investigation of returned suspect battery charger board finds that the reported error could not be replicated.Motor battery charger board passed bench level test and ran without any issues.The field service engineer replaced this board as a precautionary measure, reported problem was due to defective battery as reported in initial report.

Manufacturer Narrative

Correction: it was discovered on 27-jan-2016, that an incorrect date was referenced in a previous supplemental 3500a submission.The reported date of 16-aug-2016 was reported incorrectly and should be 16-aug-2015.Statement in previous supplemental 3500a submission should read: ¿on 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2015.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2015.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.¿.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4759365
• MDR Text Key: 5792229
• Report Number: 1723170-2015-00580
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2015,02/22/2016

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: Biomedical Engineer
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/19/2015
• Distributor Facility Aware Date: 05/26/2015
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/19/2015; 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1