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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ACTIVOX P4L US STD PKG WITH EXT BATT
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RESMED LTD ACTIVOX P4L US STD PKG WITH EXT BATT Back to Search Results
Model Number AOX-P4L-US-B
Device Problem Infusion or Flow Problem (2964)
Patient Problem Low Oxygen Saturation (2477)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to resmed for an engineering investigation.Performance testing during initial evaluation of the device revealed the device was not producing oxygen within specification.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed reference #: (b)(4).
 
Event Description
It was reported to resmed that a patient had an oxygen desaturation while using an activox 4l device.The customer reported no alarms were noted at the time of the desaturation.It was reported emergency services were contacted and the patient was placed on an alternative oxygen source.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
The activox 4l device was returned to resmed for an investigation.The investigation determined that the reported event was due to material degradation.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
 
Event Description
It was reported to resmed that a patient had an oxygen desaturation while using an activox 4l device.The customer reported no alarms were noted at the time of the desaturation.It was reported emergency services were contacted and the patient was placed on an alternative oxygen source.There was no patient harm or serious injury reported as a result of this incident.
 
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Brand Name
ACTIVOX P4L US STD PKG WITH EXT BATT
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU  2153
MDR Report Key8561606
MDR Text Key143547198
Report Number3004604967-2019-00151
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
PMA/PMN Number
K113317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberAOX-P4L-US-B
Device Catalogue NumberAOX-P4L-US-B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/07/2019
Distributor Facility Aware Date07/08/2019
Device Age8 MO
Date Report to Manufacturer08/07/2019
Date Manufacturer Received07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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