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 10/24/2022

Event Type  malfunction  

Event Description

Patient was cleared for mri.Staff member brought patient into the scanner for mri right foot then the scanner gave issues.Scanner table would not go in, centering light not recognized by the machine.Technician tried many ways to get scanner to work to no avail.Technician pulled the patient out of the scanner and sent patient back to emergency department due to getting orders to do mri on a different stat.Contributing factors: technology issues.Immediate actions: philips company called to look at scanner.Xray taken of patient's foot after failed mri; mri of right foot successfully preformed later in the day.Follow up: service has been called for table issue.This has been happening repeatedly; department manager escalated service request with philips.

• 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: 15707588
• MDR Text Key: 302783487
• Report Number: 15707588
• 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
• 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: 22265 DA
• Patient Sex: Male