MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7C - 795201; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22

Model Number EPIQ 7C - 795201

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Respiratory Distress (2045)

Event Date 04/11/2018

Event Type  Death  

Manufacturer Narrative

An investigation to determine the cause of this issue is ongoing.A follow up report will be submitted to provide additional evaluation details upon completion of the investigation.The investigation may or may not require a device return for failure analysis.

Event Description

A customer reported an infant had expired while attempting to use an epiq ultrasound system to evaluate cardiac function.The patient was delivered earlier in the day in respiratory distress which required continuous (b)(6) airway pressure (cpap).The epiq ultrasound system was intended to be used to detect congenital heart disease or primary pulmonary hypertension, but an error message was generated while booting up the system.The customer could not recover the device for use and the patient expired.The customer does not allege that the outcome would have been avoided had the system operated correctly.

Manufacturer Narrative

A thorough investigation was performed to further evaluate the reported problem.The investigation concluded the system was unable to boot-up due to a low battery error that would be corrected via a software update.The customer¿s local field service engineer has been instructed to upgrade the system¿s software to ensure the issue does not recur.The baby was delivered in respiratory distress and as reported by the hospital the cause of death was sepsis, multi system organ failure and severe metabolic acidosis, therefore it was determined that the epiq did not contribute to the patient¿s outcome.

• Brand Name: EPIQ 7C - 795201
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 7480583
• MDR Text Key: 107144734
• Report Number: 3019216-2018-00029
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 7C - 795201
• Device Catalogue Number: EPIQ 7C - 795201
• Device Lot Number: US613B0250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2015
• 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
• Patient Outcome(s): Death