MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY

Model Number V60

Device Problems Device Alarm System (1012); Failure to Power Up (1476); Device Inoperable (1663)

Patient Problems Bradycardia (1751); Death (1802); Respiratory Distress (2045)

Event Date 12/15/2016

Event Type  Death  

Event Description

Patient died as an inpatient in the intensive care unit (icu).Immediately prior to the patient's death, it was discovered by the icu nursing staff that the bipap (bi-level positive airway pressure) machine in use for the patient was not on.Nursing staff were alerted to check on the patient at 10:47 p.M.When his cardiac monitor alarm went off.The patient was bradycardic and progressed to cardiac asystole.He was also having agonal respirations at the time he was found.A respiratory therapist was immediately contacted and attempts were made to turn the bipap machine back on.Attempts to restore the machine to a functioning status were unsuccessful.Staff noted that the cardiac monitor alarmed, but the bipap machine did not alarm.The patient had the bipap mask on and condensation was noted in the mask.The patient's breathing was assisted for several minutes through the use of a mask, ambu bag and supplemental oxygen.Due to the patient having a do not resuscitate (dnr) order in place, no further attempts were made to resuscitate the patient.Engineering will send the bipap unit out to a third party for review and inspection.

• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos ct.; carlsbad CA 92011
• MDR Report Key: 6215388
• MDR Text Key: 63626737
• Report Number: 6215388
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2016
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2016
• 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 Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR