MAUDE Adverse Event Report: NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) OMNITOM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Catalog Number NL5000

Device Problems Power Problem (3010); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

Event Type  malfunction  

Event Description

Ct technologist notified that the portable ct scanner powered down in the middle of a portable ct head scan.The scan was incomplete but sufficient enough to send to pacs for diagnostic as is.During the incident, all battery indicators showed that the system was at or near full capacity.After plugging the unit in for a few minutes the techs were able to move the portable back to the storage closet and contacted neurologic for tech support.From inception this device has failed time and time again.The original purchased device was returned to the oem due to multiple failures.Several months later a second device, the current scanner, was delivered for use.The second device has failed many times over the course of the year and continues to be an unreliable resource.To prevent reoccurrence of future events the portable scanner should be removed from service and returned to the oem.

• Brand Name: OMNITOM
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS); 14 electronics avenue; danvers MA 01923
• MDR Report Key: 9995289
• MDR Text Key: 188833518
• Report Number: 9995289
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA