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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD H4I - EUR GP2, UK, AP
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RESMED LTD H4I - EUR GP2, UK, AP Back to Search Results
Model Number 26942
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 06/01/2021
Event Type  Death  
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).
 
Event Description
It was reported to resmed that the h4i humidifier of a stellar was used without water filled by the caregiver, therefore allegedly delivering dry air to the patient which contributed to respiratory deterioration and subsequent death of the patient.There is no allegation of device malfunction.
 
Manufacturer Narrative
The stellar device and h4i humidifier were returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference #: (b)(4).
 
Event Description
It was reported to resmed that the h4i humidifier of a stellar was used without water filled by the caregiver, therefore allegedly delivering dry air to the patient which contributed to respiratory deterioration and subsequent death of the patient.There is no allegation of device malfunction.
 
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Brand Name
H4I - EUR GP2, UK, AP
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key12748120
MDR Text Key279995983
Report Number3007573469-2021-01120
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUK
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 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number26942
Device Catalogue Number26942
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2022
Distributor Facility Aware Date07/24/2022
Date Report to Manufacturer07/25/2022
Date Manufacturer Received07/24/2022
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age15 YR
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