MAUDE Adverse Event Report: PHILIPS INDIA LTD. BV LIBRA, MOBILE X-RAY UNIT; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BV LIBRA, MOBILE X-RAY UNIT

Device Problem Smoking (1585)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported to philips that the system emitted smoke during a procedure.The system was in clinical use.No user or patient harm has been reported.To date, no further information was received.We are conservatively reporting this event as the investigation is ongoing.A follow up report will be submitted when further information is received.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the procedure was continued by using another device.The customer reported that the device emitted smoke and could not be used.No service has been performed by philips since the device is out of warranty and customer did not call philips for evaluation or repair service, no additional information was retrieved.To date, there have been no further reports of this issue.The codes were updated based on the investigation outcome.

• Brand Name: BV LIBRA, MOBILE X-RAY UNIT
• Type of Device: 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: 18987612
• MDR Text Key: 338727732
• Report Number: 3003768277-2024-01975
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K010762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: Health Professional
• Device Model Number: BV LIBRA, MOBILE X-RAY UNIT
• Device Catalogue Number: 718022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2010
• 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