MAUDE Adverse Event Report: RESMED, LTD ASTRAL 150 VENTILATOR; CONTINUOUS, VENTILATOR, HOME USE

Model Number 19AVE12018

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 06/13/2020

Event Type  Death  

Event Description

Nurse, (b)(6), was called to home.Upon arrival was told by mom that she put child down (in wheelchair) for a nap and she also lay down to nap.When mom awoke, she went to check on child and found her lifeless on the ventilator and it was not alarming.Mom then called 911.Ems was sent to home along with (b)(6) county coroner, (b)(6).Coroner put time of death at 2147 on (b)(6) 2020.Ems stated on their arrival, child was cold to touch under blanket and not connected to ventilator.Mom told nurse that she disconnected all of the machines when she called 911, knowing child was gone.Coroner, took body into custody along with the ventilator, as the dme company stated they could not pick it up until monday.The dme company was (b)(4).The ventilator was an astral 150.Fda safety report id# (b)(4).

• Brand Name: ASTRAL 150 VENTILATOR
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): RESMED, LTD
• MDR Report Key: 10158760
• MDR Text Key: 195282324
• Report Number: MW5095016
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 19AVE12018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 13 YR
• Patient Weight: 28