MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR; RADIOFREQUENCY GENERATOR

Model Number	RFP-100A
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the 20-minute procedural delay.A dhr review was completed and the device fulfilled all requirements prior to release.
Event or Problem Description
A 20- minute procedural delay was reported in a case where the baylis radiofrequency puncture generator (rf generator) was unable to be used for the procedure.During a cardiology procedure, the rf generator was connected to a compatible radiofrequency (rf) puncture device.Rf was attempted, however the generator would not produce rf.The generator was restarted, and a new compatible device was connected however this did not resolve the issue.An alternate baylis rf generator was setup and used for successful rf delivery.While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the 20-minute procedural delay.

• Brand Name: BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR
• Common Device Name: RADIOFREQUENCY GENERATOR
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 16315188
• Report Number: 3019751610-2023-00014
• Device Sequence Number: 17662843
• Product Code: GEI
• UDI-Device Identifier: 00685447000969
• UDI-Public: (01)00685447000969
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: RFP-100A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown