MAUDE Adverse Event Report: NEUROLOGICA CORP. CT SCANNER, NL5000; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 0-NL5000-001

Device Problems Failure to Charge (1085); Computer Operating System Problem (2898)

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

Event Date 01/13/2020

Event Type  malfunction  

Event Description

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.Batteries would not hold a charge.Device is less than one year old.

• Brand Name: CT SCANNER, NL5000
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): NEUROLOGICA CORP.; 14 electronics avenue; danvers MA 01923
• MDR Report Key: 9948025
• MDR Text Key: 187197709
• Report Number: 9948025
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0-NL5000-001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3285 DA