MAUDE Adverse Event Report: PHILIPS/RESPIRONIC, INC EVO TRILOGY; CONTINUOUS, VENTILATOR, HOME USE

Device Problems Defective Component (2292); Improper Flow or Infusion (2954)

Patient Problems Loss of consciousness (2418); Respiratory Insufficiency (4462)

Event Date 10/28/2022

Event Description

Reporter called to report a ventilator malfunctioning while being used by his daughter.He states this happed last friday, when daughter became unresponsive and had to be transferred to emergency room then icu for elevated c02 of 100%.Per reporter the ventilator was working against the machine which means it was sucking air instead of providing air.Like being suffocated.Once his daughter arrived at the hospital, they realized the home ventilator was defective and had to be put on the hospital ventilator.He further states the respiratory therapist at the hospital mentioned "2 other similar cases on different patients with the same device.".

• Brand Name: EVO TRILOGY
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): PHILIPS/RESPIRONIC, INC
• MDR Report Key: 15744551
• MDR Text Key: 303335401
• Report Number: MW5113100
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Sex: Female