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

Model Number V60

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 03mar2020.

Event Description

It was reported that the unit declared an oxygen device failure.There was no patient involvement.The device was not being used for treatment when the reported event occurred.The manufacturer's international service technician performed troubleshooting.The service technician found a "watchdog test failure" in the device log as well as the "oxygen device failed" error.The service technician replaced the unit's central processing unit (cpu) board to address the watchdog failure and the solenoid valve was replaced due to an oxygen concentration inaccuracy.The "oxygen device failure" could not be observed during functional testing; therefore, the technician concluded that this error was due to environmental factors.

Manufacturer Narrative

G4: 05jul2020.B4: 06jul2020.The central processing unit (cpu) was returned to failure investigation for analysis.The visual inspection of the cpu revealed no evidence of damage or contamination.The determination not could be made that the device failed to meet specifications, the cpu functioned as they should.No fault found with this assembly.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4 02jun2020.B4: 03jun2020.The oxygen solenoid was returned for failure analysis.A visual inspection revealed debris in the solenoid body.During testing, it was determined that the solenoid was leaking due to debris in the solenoid body.This was the root cause of the reported failure.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 9787795
• MDR Text Key: 194176244
• Report Number: 2031642-2020-00763
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1