MAUDE Adverse Event Report: PHILIPS INDIA LTD. BV PULSERA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BV PULSERA
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that the left monitor made a popping sound and smoke came out of it before turning off.There was no reported patient or user harm.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information the system was in clinical use and the customer was performing a planned treatment/non-emergency treatment.This issue occurred between patients they were able to complete current procedure and send images after monitor was replaced.It was reported that the upper right-hand side of the monitor was smoking.Upon further inspection, philips field service engineer (fse) visited onsite and confirmed that the left monitor (active monitor) made a popping sound and smoke came out of it before turning off.Fse replaced the defective monitor with new one.After the replacement of defective monitor, the system was returned to use in good working.The codes were updated based on the investigation outcome.

• Brand Name: BV PULSERA
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer (Section G): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer Contact: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19977432
• Report Number: 3003768277-2024-04394
• Device Sequence Number: 18258071
• Product Code: OWB
• UDI-Device Identifier: 00884838055506
• UDI-Public: 00884838055506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: BV PULSERA
• Device Catalogue Number: 718095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2009
• 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
• Patient Sex: Unknown