MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INGENIA MRI SCANNER; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 1.5T

Device Problems Collapse (1099); Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 01/09/2021

Event Type  Injury  

Event Description

A patient was being moved from the mri trolley back to a stretcher when the table top came off the trolley and collapsed to the floor.The patient was assisted off the table to the floor and was fortunately not injured.Fda safety report id # (b)(4).

• Brand Name: INGENIA MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 11207329
• MDR Text Key: 228209185
• Report Number: MW5098897
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1.5T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 71