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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD NV UMFFM SYS MED STD-EUR1; MASK, OXYGEN

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RESMED LTD NV UMFFM SYS MED STD-EUR1; MASK, OXYGEN Back to Search Results
Model Number 60645
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 12/31/2015
Event Type  Death  
Manufacturer Narrative
An investigation carried out by the (b)(4) hospital determined that there was no malfunction with the mask.It was reported that the physician accepted most likely cause of death was from a leak from the patient's circuit.The mask was not returned to resmed for investigation.(b)(4).
 
Event Description
It was reported to resmed (b)(4) that a hospital patient passed away due to a circuit disconnection while using a resmed ultra mirage nv full face mask with a carefusion ventilator.
 
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Brand Name
NV UMFFM SYS MED STD-EUR1
Type of Device
MASK, OXYGEN
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista, nsw 2153
AS  2153
Manufacturer Contact
david duley
9001 spectrum center blvd
san diego, CA 92123
8588365985
MDR Report Key5397488
MDR Text Key37058871
Report Number3004604967-2016-00065
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 01/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number60645
Device Catalogue Number60645
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date12/31/2015
Initial Date Manufacturer Received 12/31/2015
Initial Date FDA Received01/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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