MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Defective Alarm (1014); Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Death (1802); Low Oxygen Saturation (2477)

Event Date 04/13/2018

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.During follow-up it was reported that given the patient's medical history, was being treated by multiple departments, respiratory, cardiology and rheumatology.The patient did not stay in the icu or the hcu, but in the department of pulmonary and respiratory medicine.Initially the patient's status was a do not resuscitate (dnr).Initially, the patient was managed on intermittent 2l of oxygen via cannula.On (b)(6) 2018, the patient was placed on nppv (non-invasive positive pressure ventilation).On this same day, the nurse confirmed that the "patient disconnect" alarm did not function when the patient removed the mask.The nurse consulted with the ce about the "'patient disconnect" alarm that did not sound and also to deal with the "low minute ventilation" alarm at additional setting of 3.5l.On (b)(6), the patient's spo2 did not raise when treated with nppv, therefore the fio2 was lowered as treatment.The patient's condition worsened and resulted cardiac arrest.The patient's resuscitation took a long time and hypoxic encephalopathy and some other issues developed and the patient passed away.The patient was monitored by the patient monitors and the clinicians did not rely on the ventilator alarms.Cardiopulmonary resuscitation was not performed, only the ventilator was used.The ce at the hospital reported that the patient's death was due to disease progression and there was no causal relationship between the ventilator and the patient's death.Further information has been requested including makes and models of accessories used.The use of unapproved accessories can change the functioning of the ventilator, including alarms.

Event Description

A company representative reported that a v60 did not alarm when the amara view mask became detached.A patient being ventilated on a v60 with an amara view mask was found by a nurse when the spo2 saturation alarm rang for low saturations.The patient went into a "temporary" cardiac arrest, required intubation and was placed on another ventilator.

Manufacturer Narrative

Date of this report: 20sep2018.Date received by mfr: 20jul2018.Correction: added udi (international udi: (b)(4)); at the check performed at the repair center the unit had no abnormality.The phenomenon was determined that the cause was the compatibility of the mask.No parts were replaced.The device was used for treatment and did not cause patient harm.After performance check the device was returned to the customer.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7494204
• MDR Text Key: 107588888
• Report Number: 2031642-2018-00971
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1