MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 3.0T

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2022

Event Type  malfunction  

Event Description

Patient was brought to imaging, mri for a brain cow carotid mri.The technician reported the scans were going fine.The carotid exam is a power injected bolus with specific timing.The technician did the exam as normal.The patient is injected and the scan started when the technicians see contrast entering the carotid arteries.The technician started the scan and injection and the scanner stopped scanning after the technician injected contrast.The technician attempted to do a quick table reset in hopes of saving the scan and the scanner refused to start scanning.The patient's nurse was called and informed.The technician recommended they do another modality for carotid imaging since the technician was unable to repeat carotid boluses if they are "botched." contributing factor: technology issues immediate action: patient sent to ct for angiogram; there was no injury to patient other than required ct angio.Description of follow up: philips 3t scanner has had repeated issues with table malfunctions with various repairs performed.

• Brand Name: ACHIEVA 3.0T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; 13560 morris rd; alpharetta GA 30004
• MDR Report Key: 15707587
• MDR Text Key: 302777047
• Report Number: 15707587
• Device Sequence Number: 1
• Product Code: LNH
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3.0T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2022
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA