MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ CVX; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number 989605488741

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/08/2022

Event Type  malfunction  

Event Description

A customer reported the control panel detached from their epiq cvx ultrasound system while transporting the unit within the user facility.The arm fell forward and came to rest on the chassis.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of the reported issue, including a manufacturing evaluation and analysis of the involved monitor arm variant.The engineering team determined the failure occurred from an assembly error resulting in some control panel arm screws not being installed.Additional checks are being added to the assembly process to ensure all required fasteners are installed to prevent potential recurrence of this error.This action was reported to fda per 21 cfr part 806 on 1/6/21.Reference corrections and removal report number 3019216-01/06/21-001-c.

Manufacturer Narrative

The investigation previously had linked the customer-reported issue to fsca 79500546.However, the available information does not support that the issue reported by this customer is the same as is referenced in fsca 79500546.In this event, it was reported that the control panel articulating arm broke during transport.During our investigation, the customer declined to provide details about the positioning of the system during transport.The epiq system user manual recommends before moving the system, to retract the keyboard, move the control panel to the lowest, centered position, lock the monitor arm by pressing its articulating sections together, and secure the arm with the transport strap provided with the system.After evaluation and repair of the device, the parts replaced were discarded.Although exact root cause of the event could not be determined, the philips field service engineer concluded the event was most likely a result of the customer not adequately securing the control panel and monitor assembly in the recommended locked transport position as noted in the epiq system user manual.The fsca was initiated due to a manufacturing issue resulting in loose or missing screws, which can increase likelihood of breakage of the control panel articulating arm but is not the sole reason a control panel articulating arm can break.Our investigation showed no evidence that control panel articulating arm screws were missing or loose, and therefore it cannot be concluded that this case is related to fsca 79500546.

• Brand Name: EPIQ CVX
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 15079207
• MDR Text Key: 304508910
• Report Number: 3019216-2022-00070
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: 00884838088658
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605488741
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3019216-01/06/21-001-C
• Patient Sequence Number: 1