MAUDE Adverse Event Report: STEREOTAXIS NIOBE MNS PHILIPS; NIOBE ES

Model Number ES PHILIPS

Device Problems Self-Activation or Keying (1557); Noise, Audible (3273); Unexpected Shutdown (4019)

Patient Problem No Code Available (3191)

Event Date 06/01/2020

Event Type  malfunction  

Event Description

A patient of unknown age and gender was undergoing a vt ablation.The physician had already mapped the lv and was ablating the ventricle.In the middle of the procedure the physician was applying a field there was a loud noise that seemed to come from mp1 and then the system shut off on its own.Troubleshooting occurred immediately at the site, and the system remained down.After a short period of time of trying to bring the system back up, it was recommended that they hand crank the magnets and go to a manual approach to complete the ablation.Total delay time was approximately 45 minutes.To avoid remapping of the left ventricle, the physician completed the ablation manually and the patient remained on the table and the magnets were moved to stow position.There was no injury to the patient.There was however, significant delay of the procedure.

• Brand Name: NIOBE MNS PHILIPS
• Type of Device: NIOBE ES
• Manufacturer (Section D): STEREOTAXIS; 4320 forest park ave.; suite 100; st. louis, mo
• Manufacturer (Section G): STEREOTAXIS; 4320 forest park ave.; suite 100; st. louis, mo
• Manufacturer Contact: adam miller ; 4320 forest park ave.; suite 100; st. louis, mo ; 6786250
• MDR Report Key: 10268322
• MDR Text Key: 201544149
• Report Number: 3003084417-2020-00218
• Device Sequence Number: 1
• Product Code: NDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ES PHILIPS
• Device Catalogue Number: 001-006100-1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1