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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD OBSOLETE VPAP IV AP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESMED LTD OBSOLETE VPAP IV AP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number 26109
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Respiratory Insufficiency (4462)
Event Type  Injury  
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.The vpap iv user guide provides the following indications for use: ¿the vpap iv and the vpap iv st are intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea (osa), in the hospital or home.¿ it is not intended to be used as a life support ventilator, as this device does not offer therapy and device alarms, and does not have internal battery.It is only intended to provide ventilation to a spontaneously breathing patient as it is not a life support ventilator.In the event of device failure, an indicated patient would be able to continue breathing spontaneously until an alternative means of ventilation support can be provided.Resmed reference#: (b)(4).
 
Event Description
It was reported to resmed that a patient using a vpap iv device experienced desaturation to 30%, chest tightness and shortness of breath when the device allegedly stopped operating unexpectedly.The patient was removed from the device and placed on another device.
 
Manufacturer Narrative
The vpap iv device was returned to resmed for an investigation.Review of the device data logs revealed an alarm (107a).Based on all available evidence, the investigation determined that the reported complaint was due to liquid contamination of the motor.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.The vpap iv user guide provides the following indications for use: - ¿the vpap iv and the vpap iv st are intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea (osa), in the hospital or home.¿ it is not intended to be used as a life support ventilator, as this device does not offer therapy and device alarms, and does not have internal battery.It is only intended to provide ventilation to a spontaneously breathing patient as it is not a life support ventilator.In the event of device failure, an indicated patient would be able to continue breathing spontaneously until an alternative means of ventilation support can be provided.Resmed reference#: (b)(4).
 
Event Description
It was reported to resmed that a patient using a vpap iv device experienced desaturation to 30%, chest tightness and shortness of breath when the device allegedly stopped operating unexpectedly.The patient was removed from the device and placed on another device.
 
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Brand Name
OBSOLETE VPAP IV AP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
Manufacturer (Section G)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS   2153
Manufacturer Contact
michelle hughes
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS   2153
MDR Report Key16211049
MDR Text Key307770826
Report Number3004604967-2023-00043
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number26109
Device Catalogue Number26109
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/19/2023
Date Manufacturer Received06/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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