MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7 C ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number 795200

Device Problem Unintended System Motion (1430)

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

Event Date 07/12/2021

Event Type  malfunction  

Event Description

The customer reported that the rotary arm locking device of the ultrasonic system control panel has malfunctioned, resulting in incorrect locking on their epiq 7c ultrasound system.There was no adverse patient or user impact associated with this event.An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.

Manufacturer Narrative

Previously reported, the rotary arm locking device of the ultrasonic system control panel had malfunctioned, resulting in incorrect locking on their epiq 7c ultrasound system.There was no adverse patient or user impact associated with this event.The customer confirmed the issue was misreported and there was no actual occurrence.

Manufacturer Narrative

An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.

• Brand Name: EPIQ 7 C ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 16395263
• MDR Text Key: 309746842
• Report Number: 3019216-2023-00019
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097865
• UDI-Public: (01)00884838097865
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: 795200
• Device Catalogue Number: PB016180
• Device Lot Number: 795200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1