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

Model Number NL 5000

Device Problems Positioning Problem (3009); Unintended Movement (3026)

Patient Problem Physical Entrapment (2327)

Event Date 03/12/2020

Event Type  malfunction  

Event Description

Portable ct machine (omnitom) was taken to the floor for a head ct at approximately 1000am.When trying to maneuver the machine sideways towards the baby's head.The ct "maching" took a different turn and pinned the operator against the glass door and kept pinning her around the diaphragm/lower ribs area for a few seconds.Staff member was taken to the ed by colleagues.Device operator was checked out by ed and received treatment as a result of this incident.

• 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: 10017115
• MDR Text Key: 189612039
• Report Number: 10017115
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NL 5000
• Device Lot Number: LPCH 63768
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1