MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Catalog Number BI70002000

Device Problems Thermal Decomposition of Device (1071); Circuit Failure (1089); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

09/24/2015 and 09/29/2015 a medtronic representative performed imaging system check-outs.In both, imaging modalities, cable grade, safety inspection areas passed.Mechanical test failed due to a charging issue.- 10/08/2015 a medtronic representative performed an imaging system check-out, cable grade, safety inspection areas passed.Imaging modalities test and mechanical test failed.Noted that the imaging system could not be turned on and required repair.- the medtronic representative was at the site to address the problems found in the imaging system check-outs.This occurrence was an anomaly.- no parts have been received by manufacturer for analysis.- no further issues have been reported.

Event Description

A medtronic representative reported that, while servicing a medtronic imaging system, another medtronic representative caused a spark.The service technician was on-site to trouble-shoot the imaging system.Upon arrival the system was opened and the battery voltages were measured.It was found that on tray 3, voltages were 3,88vdc for battery pair 1-2 and 10 vdc for battery pair 3-4, also fuse 2 was blown.On tray 2, the voltage was 0vdc for battery 1-2 and 27vdc for battery 3-4 and fuse 3 was blown.All the other voltages where ok.Based on the afore mentioned findings we planned to close-up the imaging system and share the information for ordering parts.However, when connecting the high power connector back, due to some aligning difficulties, it likely flipped to the right side, touching the switch lever.This caused a spark and burned out the power connector.The connector has its contacts which are black but the housing of it was damaged.There was no patient present when this issue was identified.There was no potential for patient harm.There was no harm to the medtronic representative servicing the imaging system.

Manufacturer Narrative

Medtronic investigation of returned system finds that there was an unintentional "battery to chassis" short by a field service engineer (fse) on the imaging system.The evidence suggests that the corner of the power tray and the tip of the toggle switch in the power tray had contacted the battery feed connector.Initial observations were that the battery feed connector to the power tray had contacted the edge of the power tray resulting in one arcing event, and another arcing event occurred when the same connector contacted the tip of the toggle switch in the power tray.It cannot be determined which event had occurred first, although it appears that both events had occurred within seconds of each other.A visual inspection of the system found that most of the damage was limited to the power tray.Although other damage included the battery feed connector, and some minor heat damage to the battery cage.The ground wire, which connects chassis to battery tray 4, showed some smoke damage, but otherwise in good condition.The charger assembly and the power conversion assembly were found on the system with no visible damage in either of assemblies.The assemblies were provided to an electrical engineer for functional testing: charger assembly - the charger was examined and it was determined that on application of power, two chargers (#7 & #9) were not communicating, but all others were.After a few minutes, charger #5 stopped operating also.In all three chargers the +3.3v voltage regulator was damaged.Substituting a lab supply brought each back to life.It was also noticed that one of the chargers (#2) had a shorted output protective tvs diode.The probable cause of damage in all four chargers (#2, #5, #7 and #9) is output voltage reversal or extreme dv/dt during the event or subsequent arcing as the circuit broke.Power conversion assembly - there is no obvious evidence of damage to this unit, and it works normally with one exception which is unrelated to the accident during servicing.That is, the assembly incorrectly reports a temperature of over 150°c and the corresponding over temperature error is also flagged.The temperature is sensed by a tiny sot-23 sized 3 pin temperature sensor.Upon investigation, it was discovered that one pin of the device is separated from the board due to what appears to be a cold solder joint.When connected, the error goes away and the temperature is reported normally.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5174780
• MDR Text Key: 29846199
• Report Number: 1723170-2015-01278
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2015
• 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