MAUDE Adverse Event Report: BAYER MEDICAL CARE INC.; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number STELLANT 2787

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

# 1 patient was having a routine ct scan and returned to the floor in stable condition.Radiology called nurse and told her that the scan showed air in the right ventricle.Primary team of doctors were notified and patient was placed on bedrest per doctor¿s order.Patient transferred to the pediatric intensive care unit for further evaluation.Repeat echo showed no embolus and he had no symptoms.(b)(6) y/o.No harm noted.# 2 patient was having a routine ct scan and returned to the floor in stable condition.Radiology called nurse and told her that the scan showed air in the right ventricle.Primary team of doctors were notified, and patient was placed on bedrest per doctor¿s order.Echo not completed after review by echo lab/cards fellow who felt this was not the appropriate test and to complete a chest x-ray (cxr).Cxr with no air noted in the mediastinum.No harm noted.

• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 12688310
• MDR Text Key: 278100693
• Report Number: 12688310
• 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
• Type of Report: Initial
• Report Date: 10/20/2021

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: No Information
• Device Model Number: STELLANT 2787
• Device Lot Number: 8600276
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1