MAUDE Adverse Event Report: EPIQ 5; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A thorough investigation was performed which included an engineering evaluation of the swivel mechanism bushing moving out of position.The displaced bushing prevented the control panel from locking properly.The philips field service engineer removed and reseated the bushing to resolve the issue.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.
Event or Problem Description
The customer reported the swivel mechanism of their epiq ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility and during clinical use.No patient or user was harmed as a result of the issue.The system has been returned to service with no additional issues reported.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.The engineering team determined the failure was caused by a hardware issue in the articulating arm latching mechanism preventing the locking solenoid from fully engaging.Additional actions to prevent this failure from occurring are underway.
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.The engineering team determined the failure was caused by a hardware issue in the articulating arm latching mechanism preventing the locking solenoid from fully engaging.Additional actions to prevent this failure from occurring are underway.
Event or Problem Description
The customer reported the swivel mechanism of their epiq ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility and during clinical use.No patient or user was harmed as a result of the issue.The system has been returned to service with no additional issues reported.

• Brand Name: EPIQ 5
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• MDR Report Key: 11171269
• Report Number: 3019216-2021-00006
• Device Sequence Number: 2766330
• Product Code: IYN
• UDI-Device Identifier: 00884838097902
• UDI-Public: 00884838097902
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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
• Operator of Device: Health Professional
• Device Model Number: EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795205
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/21/2020
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 12/21/2020; 12/21/2020
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 06/02/2021; 08/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2017
• 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: Reuse
• Patient Sequence Number: 1