MAUDE Adverse Event Report: NEUROLOGICA CORP. OMNITOM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 0-NL5000-001

Device Problems Failure to Power Up (1476); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2020

Event Type  malfunction  

Event Description

Portable head scan was requested for (sdh) for patient in cvicu.I went to 3rd floor where are omni-tom portable head scanner is located.When turned on machine an error message came up stating that the drive bar failed and to call service.We were told to bring down scanner and wiggle the drive bar to clear message.On 3rd try the scanner turned on but when i tried to move the scanner, it would not allow me to bring all the way up in order for scanner to move nor would it allow me to bring the scanner all the way down in order to scan.There is an arrow that must turn gray letting you know that the scanner is in ready position to be moved or to scan.I called service and spoke to them.We did a few things such as reboot scanner and look under scanner to check the wheels.The rep then said they would be calling someone to come out to take a look and service the scanner.When i went back to let them know i was having an issue with scanner and that i would need to go get the other scanner and table (which would have taken about 45 minutes to an hour).I was told that they were going to cancel the exam for now.The neurologica omnitom would not boot up or start from the powered down state.Multiple attempts tried.Scan delayed due to this.Quality of imaging decreased because of having to use older, lesser ceretom instead.

• Brand Name: OMNITOM
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): NEUROLOGICA CORP.; 14 electronics avenue; danvers MA 01923
• MDR Report Key: 9675979
• MDR Text Key: 177959621
• Report Number: 9675979
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0-NL5000-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 DA