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

Model Number CORE01

Device Problem Sharp Edges (4013)

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

Event Date 02/06/2023

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.Block h6: 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.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 core system touchscreen was shattered.There was no patient present and no user injury reported.The touchscreen monitor was returned for evaluation.Visual inspection confirmed a crack with sharp edges observed.This product problem is being reported in an abundance of caution because the touchscreen monitor has sharp edges that can result in a potential for harm.

Manufacturer Narrative

Blocks d and g: street address was updated from "(b)(6)" to "(b)(6)." 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: CORE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS VOLCANO; 2451 mercantile drive; rancho cordova CA 95670
• Manufacturer (Section G): VOLCANO CORPORATION; 2451 mercantile drive; rancho cordova CA 95670
• Manufacturer Contact: ayse yarimoglu ; 2451 mercantile drive; rancho cordova, CA 95742 ; 858720-406
• MDR Report Key: 16777551
• MDR Text Key: 314090400
• Report Number: 2939520-2023-00002
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00845225010300
• UDI-Public: (01)00845225010300(11)190314(90)989609000071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153369
• 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: 08/02/2023

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: CORE01
• Device Catalogue Number: 300004330631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2019
• 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