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

Model Number 797403

Device Problem Sharp Edges (4013)

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

Event Date 05/12/2022

Event Type  malfunction  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacture¿s policy.At the customer site, a field service engineer replaced the cracked intrasight system''s touchscreen monitor and verified operation.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 power on the intrasight system''s touchscreen monitor was intermittent and the monitor was cracked with sharp edges.There was no patient involvement and no user injury reported.This product problem is being reported in an abundance of caution because the touchscreen monitor was cracked with sharp edges that can result in a potential for harm.

Manufacturer Narrative

Block h3: the touchscreen monitor was returned for evaluation.Visual inspection confirmed a crack with missing screen material, resulting in sharp edges.Block h6: correction, investigation findings code from "3243" to "3252".The complaint codes listed in the initial mdr remain acceptable (10- type of investigation and 61- investigation conclusion).Based on the returned screen, the probable cause is likely damaged from use.The device integrity can be affected by external factors such as device manipulation, its impact, and applied pressure associated with use and handling.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.

• 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; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14636124
• MDR Text Key: 301751902
• Report Number: 3008363989-2022-00031
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(11)190709(90)300000437312
• 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,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2019
• 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