OMNITOM 0-NL5000-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for OMNITOM 0-NL5000-001 manufactured by Neurologica Corp..

Event Text Entries

[177959621] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9675979
• MDR Report Key: 9675979
• Date Received: 2020-02-06
• Date of Report: 2020-01-15
• Date of Event: 2020-01-08
• Report Date: 2020-01-15
• Date Reported to FDA: 2020-01-15
• Date Reported to Mfgr: 2020-02-06
• Date Added to Maude: 2020-02-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OMNITOM
• Generic Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Product Code: JAK
• Date Received: 2020-02-06
• Model Number: 0-NL5000-001
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NEUROLOGICA CORP.
• Manufacturer Address: 14 ELECTRONICS AVENUE DANVERS MA 01923 US 01923

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-06