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

Model Number V60

Device Problems Device Displays Incorrect Message (2591); Ventilation Problem in Device Environment (3027)

Patient Problems Respiratory Distress (2045); Loss of consciousness (2418)

Event Date 02/19/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.(b)(6).

Event Description

The customer reported the patient rang the bell.Hospital staff entered the patient's room.The patient was found unconscious and not breathing.The v60 was not alarming and was no longer providing respiration.A normal monitor screen could be seen on the device with the message "no air supply." the respiration mode was then set to pcv mode and o2 was set to 100%.The device still did not alarm and did not provide respiration.The patient was disconnected from the device and provided with air through a resuscitation bag until a replacement ventilator was provided.Patient information has been requested.

Manufacturer Narrative

Patient information was requested, unavailable at the time of this report.The customer reported the alarm had not been silenced and the distributor reported the alarm was not set to the minimum volume at the time of the reported event.Performance verification testing was completed and no abnormalities were found.Review of the device diagnostic history indicated an occurrence of a patient circuit occluded reference code on the date of the reported incident, and on the day prior to the date of the reported event.There are also occurrences of oxygen not available reference codes on the day prior to the reported incident.The device was removed from service and sent to a 3rd party service bench for further evaluation and repair.

Manufacturer Narrative

The device was tested by a technician from the service provider, (b)(4).The technician found no abnormalities or indications that the device failed.A summary of the technician's report was provided to the manufacturer.As a result of the reported issue being unconfirmed (b)(4), the service provider, did not return the device to the clinic.(b)(4) reported they designated the device to be used for demonstration purposes only, not for use on patients.

Manufacturer Narrative

During review of the ventilator diagnostic log it was noted that the date of the event was (b)(6) 2017.The patient was placed on a spontaneous/timed (s/t) mode of ventilation.The respiratory rate was set at 12 and the lower respiratory rate (rr) alarm was set at 1.The lower respiratory rate alarm setting would be defeated with this set up due to the mandatory backup rate.In addition a review of the diagnostic log does not show any low tidal volume, low inspiratory pressure or low minute volume alarms and would suggest that these alarm settings were set at off and would account for the ventilator not alarming.The customer reported the ventilator showed a message of, ¿no air supply¿, there are no such error messages in the v60 ventilator.The diagnostic log does show an ¿o2 unavailable¿ alarm approximately five minutes after the event was reported to have started.In addition the diagnostic log revealed that the patient was placed back on the ventilator again prior to being placed on an alternate ventilator.The patient was put on pressure control ventilation at 02:46am with fio2 of 100% for approximately 26 minutes.

• 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: denyse murphy ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 6394491
• MDR Text Key: 69560363
• Report Number: 2031642-2017-00860
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• 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
• Patient Outcome(s): Life Threatening