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 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacture¿s policy.No patient involvement.Block suspect product(s): not applicable.Lot# and expiration date are not applicable.At the customer site, a field service engineer replaced the cracked intrasight system's touchscreen monitor.The probable cause of the reported failure is likely due to physical damage.The device integrity can be affected by external factors such as device manipulation, its impact, and applied pressure associated with use and handling.Blocks recall (if recall number is given) or correction/removal number (if given) & list correction/removal reporting number : 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 manufacturer's system's touchscreen monitor was cracked.There was no patient involvement.No user injury reported.During the product return evaluation, multiple cracks were observed across the screen with missing pieces of material and a sharp edge.This product problem is being reported in an abundance of caution because the touchscreen monitor was cracked with a sharp edge that can result in a potential for harm.

• 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): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 13895591
• MDR Text Key: 297766947
• Report Number: 3008363989-2022-00021
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(11)190627(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
• Report Date: 07/09/2021

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: 797403
• Device Catalogue Number: 797403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• 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