MAUDE Adverse Event Report: PHILIPS VOLCANO CORE M2; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	M2
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufactures policy.A field service engineer replaced the touch panel display on the core m2 system at the customer site.
Event or Problem Description
It was reported that the manufacturer's system's touch panel glass is chipped and beginning to feel sharp to the customer.No user injury reported.This product problem is being reported because the touch panel display has a sharp edge that can result in a potential for harm.
Additional Manufacturer Narrative
Blocks d9 & g3: core m2 system touch panel screen was returned for evaluation.Block h3: during the product return evaluation, cracks and chips were observed on the screen with missing pieces of material and sharp edges.Block h5: correction, the initial mdr indicated "labeled for single use?" as yes; however, this should be no.Block h6: the complaint codes listed in the initial mdr remain acceptable (10- type of investigation, 3252- investigation findings, and 61- investigation conclusion).Based on the returned screen, the probable cause of the reported failure is likely due to unexpected damage during routine use.The device integrity can be affected by external factors such as device manipulation, its impact, and applied pressure associated with use and handling.

• Brand Name: CORE M2
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: ana tan ; 2870 kilgore road; rancho cordova, CA 95670
• MDR Report Key: 12304895
• Report Number: 2939520-2021-00046
• Device Sequence Number: 3532545
• Product Code: IYO
• UDI-Device Identifier: 00845225012663
• UDI-Public: (01)00845225012663
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: M2
• Device Catalogue Number: 400-0100.17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown