MAUDE Adverse Event Report: PHILIPS VOLCANO INTRASIGHT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 797403

Device Problem Smoking (1585)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacture¿s policy.Blocks a2-a5: no patient involvement.Blocks b6 & b7: no patient involvement.Block c: not applicable.Block d4: lot# and expiration date are not applicable.Blocks d6, d7, & d10: not applicable; no patient involvement.Blocks h3 & h6: at the customer site, an fse replaced the workstation, reconfigured the system, and set x-ray configuration.Ao calibration was performed and verified all system performance.Blocks h7 & h9: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

It was reported that the intrasight system displayed no video in the exam room or the control room monitor.The power switch was toggled off, and when the power was switched back on, smoke was detected from the back of the cpu (near the top).No sparks or damage were observed.There was no patient involvement and no user injury reported.This product problem is being reported because the intrasight had presence of smoke.There is a potential for harm if it were to recur.

• Brand Name: INTRASIGHT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): PHILIPS VOLCANO; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-403
• MDR Report Key: 19160852
• MDR Text Key: 341374091
• Report Number: 3008363989-2024-00022
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(11)200724(90)300000437313
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 797403
• Device Catalogue Number: 797403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1