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

Model Number BV ENDURA, MOBILE X-RAY UNIT

Device Problem Smoking (1585)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

It has been reported to philips that there was smoke on the acquisition monitor.The system was not in clinical use when this occurred.There was no report of harm.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that smoke on the acquisition monitor.Upon functional testing, fse found busted lcd monitor.The fse recommended customer to replace touch screen monitor.However, customer is out of contract with philips, therefore a quotation has been issued.The system was returned to use in good working order with one monitor.The codes were updated based on the investigation outcome.

• Brand Name: BV ENDURA, 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: srinivas nss ; plot no. b-79, midc,; phase-ii, chakan; pune 41050-1 ; IN 410501
• MDR Report Key: 16866687
• MDR Text Key: 314526395
• Report Number: 3003768277-2023-02671
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K010435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BV ENDURA, MOBILE X-RAY UNIT
• Device Catalogue Number: 718073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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