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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. PHILIPS V60 BIPAP; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS CALIFORNIA, INC. PHILIPS V60 BIPAP; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)
Event Date 02/17/2021
Event Type  malfunction  
Event Description
Received call from monitor tech that pt in the 40% spo2.When i arrived pt was barely responsive and saw the bipap/vent machine screen, which read error with black screen.The bipap face mask was still applied and not removed.I had vocera but was not able to make any call due to misconnection, so i pressed code blue button for further assistance.Compressions was started due to unresponsive state.Initial heart rhythm was sinus bradycardia pulseless electrical activity (sb-pea), cardiopulmonary resuscitation (cpr) and bag valve mask ventilation (bvm) initiated for 1 minute after learning the patient was limited code bipap only.Patient bounce back and heart rate is at 130 and oxygen sats is 94% on bvm.Patient back on the bipap but remain unresponsive.Sitter at bedside.
 
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Brand Name
PHILIPS V60 BIPAP
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct
carlsbad CA 92011
MDR Report Key11655468
MDR Text Key245097645
Report Number11655468
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/29/2021,03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/29/2021
Date Report to Manufacturer04/13/2021
Type of Device Usage Unknown
Patient Sequence Number1
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