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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS INC BIPAP VISION; BIPAP MACHINE
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RESPIRONICS INC BIPAP VISION; BIPAP MACHINE Back to Search Results
Model Number VISION
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Low Oxygen Saturation (2477)
Event Date 02/14/2018
Event Type  malfunction  
Event Description
Bipap machine is rented from a third party provider and has been returned to the third party.Patient was on bipap and desaturating.Pulse ox which was reading 87% and dropping on bipap.Connections and tubing immediately checked.Everything seemed to be connected.Check vent light was on and pressures were all reading zero so i immediately took pt off bipap and placed pt on a flushed oxymask.I turned the bipap off and restarted it to do the pre-use test.As soon as the bipap was turned back on the vent inop light turned on.Rapid response called.I immediately started bagging the pt.
 
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Brand Name
BIPAP VISION
Type of Device
BIPAP MACHINE
Manufacturer (Section D)
RESPIRONICS INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key7458056
MDR Text Key106433776
Report Number7458056
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberVISION
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2018
Event Location Hospital
Date Report to Manufacturer04/12/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age64 YR
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