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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME)
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RESMED LTD ASTRAL 150 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME) Back to Search Results
Model Number 27003
Device Problems Contamination (1120); Moisture Damage (1405)
Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)
Event Date 10/27/2021
Event Type  Injury  
Event Description
It was reported to resmed that a patient using an astral device while at home went into respiratory/cardiac arrest and was admitted to the hospital.On multiple occasions, water rain-out at the expiratory block allegedly led to the expiratory flow sensor chip failing due to excessive moisture causing the ventilator to malfunction.Excess water removed from filter, filter replaced and 10 to 12 flow sensors replaced with no resolution.On 2 separate occasions, patient was placed on an alternate, non-resmed ventilator.Subsequently, patient went into cardiac arrest.
 
Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.Resmed reference#: (b)(4).Fda reference#: medwatch (b)(4).
 
Manufacturer Narrative
The astral device was returned to resmed for an investigation.As per the resmed internal investigation report regarding device with serial number (b)(6), learn circuit test failed with error code 600 four times according to the device data logs.Error code 600 indicated the expiratory flow sensor was not able to be calibrated.The learn circuit function determines the impedance and compliance of the circuit and to confirm correct circuit type is properly connected.Astral user guide recommends the learn circuit function be performed with every change of circuit configuration and at regular intervals to ensure optimum and accurate performance.Review of the device¿s alarm logs revealed alarm message ¿check circuit and filters for blockages, leak or water.Repeat learn circuit.¿ occurred 154 times.This indicated a failure with the device circuit.It was a medium priority alarm.The device indicated this event with both a visual and acoustic alarm signal.Specifically, a yellow alarm bar message appeared on the device¿s user interface and the alarm led flashed yellow.The device also sounded 3 beeps every 10 seconds.The alarm cannot be muted and is not resettable until resolved.Based on an investigation and inspection of astral serial number (b)(6), condensation/water ingress on the expiratory flow sensor resulted in incorrect flow measurement on the expiratory side leading to alarms triggered and learn circuit test failure.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: pr (b)(4).Fda reference#: medwatch (b)(4).
 
Event Description
It was reported to resmed that a patient using an astral device while at home went into respiratory/cardiac arrest and was admitted to the hospital.On multiple occasions, water rain-out at the expiratory block allegedly led to the expiratory flow sensor chip failing due to excessive moisture causing the ventilator to malfunction.Excess water removed from filter, filter replaced and 10 to 12 flow sensors replaced with no resolution.On 2 separate occasions, patient was placed on an alternate, non-resmed ventilator.Subsequently, patient went into cardiac arrest.
 
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Brand Name
ASTRAL 150 - AMER
Type of Device
VENTILATOR, CONTINUOUS (FACILITY/HOME)
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key13080700
MDR Text Key283818506
Report Number3007573469-2021-01261
Device Sequence Number1
Product Code NOU
UDI-Device Identifier00619498270033
UDI-Public(01)00619498270033(11)210729(10)1551373
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number27003
Device Catalogue Number27003
Device Lot Number1551373
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2023
Distributor Facility Aware Date04/17/2023
Device Age3 MO
Event Location Home
Date Report to Manufacturer05/05/2023
Date Manufacturer Received04/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient SexFemale
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