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

Model Number V60

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

During periodic maintenance, the manufacturer¿s international service technician found that the oxygen concentration test revealed that the measured oxygen concentration was out of the specification.There was no patient involvement.

Manufacturer Narrative

During further investigation (fi), a visual inspection of the gas delivery solenoid valve assembly revealed no signs of damage or contamination.The o2 solenoid valve was installed in an fi test ventilator.The high-pressure leak test (pvt test 2), o2 flow accuracy test (pvt test 6) and the o2 accuracy test (pvt test 7) were performed an all passed.The ventilator was run with 60% o2 setting for at least one hour without errors occurring.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is no relationship of the device to the reported problem.The customer returned o2 solenoid valve was installed in an fi test ventilator.The high pressure leak test was executed passed.The oxygen accuracy test and the oxygen accuracy test were executed and both passed.The ventilator was run for two hours without errors occurring.No failure was found.

• 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: 7154645
• MDR Text Key: 96223221
• Report Number: 2031642-2017-03924
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• 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