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

Model Number EPIQ 7G DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Battery Problem (2885)

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

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

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 Description

A philips field service engineer reported encountering an incident where a lithium ion battery failed within customer's epiq ultrasound system.The system was out of use for repair at the time of the event.During the repair, the service engineer witnessed smoke coming from the system.The service engineer suspected the battery was the cause of the smoke, so the system was removed from the facility.The service engineer removed the battery pack from the enclosure and noted it was burning.The flame was promptly extinguished.There was no report of harm, injury or property damage as a result of the issue.

Manufacturer Narrative

An investigation was performed by product engineering to assess the reported issue.Due to the hazardous condition of the failed battery and the shipping restrictions for damaged/defective lithium batteries, the device could not be returned for a detailed failure analysis from philips or the supplier.However, evidence reviewed by philips electrical engineering confirmed the battery underwent thermal runaway.Thermal runaway is an extremely rare event caused by several possible flaws within a cell which causes a reaction that spreads to the other cells in the battery.When this unavoidable issue does occur, the battery is contained in a metal enclosure behind a plastic shroud that protects patients and users from contact with the failed battery.

• Brand Name: EPIQ 7
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 11842706
• MDR Text Key: 251211444
• Report Number: 3019216-2021-10061
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: 00884838047693
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 7G DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795200
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1