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

Catalog Number 795200

Device Problem No Device Output (1435)

Patient Problem Cardiac Arrest (1762)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

H10: initially, it was reported the epiq 7 ultrasound system was associated with a patient death event.However, additional information clarified the philips ultrasound system did not cause or contribute to the patient death.The device was inadvertently damaged by a staff member and not used on the patient being resuscitated.Since the device was intended to be used, the device was not available for use during a critical procedure.H11: device problem code has been updated to output problem, no device output.Type of reported complaint has been updated to product problem adverse event/product problem has been updated to product problem.

Event Description

It was reported the epiq 7 ultrasound system was associated with a patient death event.A patient was located in the icu intensive care unit of the facility and required resuscitation.The ultrasound system would have been used during the resuscitation efforts; however, when the staff member retrieved the system from the storage room, it was overlooked the system was connected to the power supply and the plug was torn out of the socket.Due to the damage of the device that occurred, the device was not used on the patient, but rather another device was used.The service engineer evaluated the system and found the system could be turned on and started.The system logs showed batteries and ac power failures.The original power cable was not installed.The power supply, power cable and batteries were ordered for replacement.

• Brand Name: EPIQ 7
• 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: 19003258
• MDR Text Key: 339288096
• Report Number: 3019216-2024-00046
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: 00884838047693
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 795200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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