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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS BIPAP VISION; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS, INC. RESPIRONICS BIPAP VISION; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number 582059
Device Problem Ventilation Problem in Device Environment (3027)
Patient Problems Bradycardia (1751); Cardiopulmonary Arrest (1765); Low Oxygen Saturation (2477)
Event Date 08/16/2015
Event Type  Injury  
Event Description
Bi-pap machine was not alarming when the device was pulled off of patient.Once the bi-pap was placed back on the patient, it was failing to ventilate the patient.The patient continued to decline, and oxygen saturations dropped.The patient became bradycardic and an emergency response was necessary.The patient became pulseless and cpr was initiated.Atropine 0.5 mg was given, one round of compressions, and the patient was intubated.
 
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Brand Name
RESPIRONICS BIPAP VISION
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
1010 murry ridge lane
murrysville PA 15668
MDR Report Key5107309
MDR Text Key26903004
Report Number5107309
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 09/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number582059
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/11/2015
Event Location Hospital
Date Report to Manufacturer09/11/2015
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 Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age50 YR
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