OMNITOM NL5000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for OMNITOM NL5000 manufactured by Neurologica Corporation (subsidiary Of Samsung Electronics).

Event Text Entries

[181361154] Situation: our new portable ct scanner (the omnitom) keeps malfunctioning and keeps on breaking down in the most critical moments. Today we had a portable ct stroke code stat. We were instructed to use the new portable ct scanner (the omnitom) as much as we can by our team because eventually our radiology department is going to get rid of the old portable ct scanner (the ceretom). The night before, we tried to start up the omnitom scanner, and the scanner was not working. We did not have any patients, but i called the (neurologica company omnitom) service and i asked for a field engineer from the omnitom company (neurolgica) to call me so the new portable ct scanner could get serviced as soon as possible. The tech support man : [name] told me that they do not service their machines over the weekend. I still gave him my department phone number and my personal phone number and told him to try to find someone. No one got back to me saturday. I left at 1930 and instructed the ct technologists to use the old portable ct scanner (the ceretom) in case of an emergency). I came this morning, we had a portable stroke code from the cvicu. The omnitom was not fixed, so we had to use the ceretom. We had no issues and the scan was done in a timely manner. The problem will arise when we get rid of the ceretom and the omnitom fails again. We will then be forced to ask the units to bring their patients down to the ct department. After this was said and done, around 1400 the regional manager name [name] called me back from neurologica. He tried to troubleshoot the problem with me over the phone for about 20 minutes. After we tried everything, he concluded that this is not an issue that could be resolved over the phone, and that he would have to send a field engineer to come take a look at the machine. I told him that this is a level 1 trauma center and our patient population is very critical and that we needed someone to take a look at this scanner yesterday. He told me that his company does not service their equipment on the weekends. This was disturbing coming from the field manager. I asked him for a service ticket number and he told me that his company does not provide those either until a field engineer is actually dispatched. He told me that someone should be in touch with us this week to resolve this issue. Background: we (the ct department in radiology) have purchased a brand new portable ct scanner that came with many promised bells and whistles. ( scanner's name is omnitom). It was to replace the older ct portable (the ceretom) which was an older unit which was manufactured in 2009. The omnitom was a faster scanner, promised more scanning options and more versatility with scanning our critical picu and cvicu patients. It was supposed to be the most sophisticated state of the art portable ct scanner in the market. Perfect for the pediatric critical population of patients we treat in our facility. This is what myself and my upper management were under the impression of anyway. It made sense to us to purchase the latest and greatest and get rid of the outdated ceretom scanner. Assessment: the omnitom scanner does not do what has been promised. It breaks down almost every 2 weeks. It is not a reliable piece of equipment. I personally do not feel safe around it when scanning ecmo patients because of it's unpredictability and sudden crashing. I am a radiology supervisor but also a senior ct technologist myself along with the other senior ct technologists. We all do not feel that this scanner is safe or reliable. We will especially feel very uneasy if the ceretom scanner were to be disposed of, and that the unpredictable omnitom scanner was our only portable scanner. I have spoken to my upper management about this. We all agree that we all have the same goal. Patient safety comes first. If i do not feel safe with this piece of equipment, i am not going to my patient's life in danger, or delay patient care because of it. Recommendation: please don't dispose of the ceretom until we finally figure out what's wrong with the omnitom and we test run it multiple times and we have it for multiple months without issues. Consider another reliable vendor for a portable ct scanner like (siemens) since we already have their 128 slice scanner and their technology is impeccable (i can say this from over 15 years of experience with their machines) please prepare the units for emergencies just in case the portable does crash how they could get down to the ct department the speediest way possible and if there is any way there is for us to assist them.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9769123
MDR Report Key9769123
Date Received2020-02-28
Date of Report2020-02-26
Date of Event2020-02-09
Report Date2020-02-26
Date Reported to FDA2020-02-26
Date Reported to Mfgr2020-02-28
Date Added to Maude2020-02-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOMNITOM
Generic NameCOMPUTED TOMOGRAPHY X-RAY SYSTEM
Product CodeJAK
Date Received2020-02-28
Model NumberNL5000
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS)
Manufacturer Address14 ELECTRONICS AVENUE DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-28

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