MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. PANORAMA 1.0T

Model Number PANORAMA 1.0T

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2021

Event Type  Injury  

Event Description

Philips received a report on an attraction incident on a panorama 1.0t mr system.A user sustained an injury, level unknown.

• Brand Name: PANORAMA 1.0T
• Type of Device: PANORAMA 1.0T
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12857464
• MDR Text Key: 281203430
• Report Number: 3003768277-2021-10238
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K041602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PANORAMA 1.0T
• Device Catalogue Number: 781250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male