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

Model Number	V60
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2015
Type of Reportable Event	Malfunction
Event or Problem Description
This report with manufacturer is being submitted as a correction to replace manufacturer report.Fda requested the submission of a missing follow up.Upon review, it was determined that the manufacturer site number is incorrect resulting in incorrect report number.The customer reported the ventilator is giving oxygen value issues.The customer stated that the ventilator was displaying erroneous oxygen values, and a leak was suspected.The customer reported the unit was not in use on a patient at the time of the reported problem.The field service engineer (fse) arrived on site and was able to duplicate the reported problem and replaced the o2 solenoid valve as a repair action.After all the repairs were completed, the device passed its performance tests.The o2 solenoid valve was returned to the factory for further analysis.At the factory, the valve was thoroughly tested, and the customer's issue was replicated.An evaluation of the solenoid valve found debris particulates that prevented the valve from closing properly and allowing for o2 to leak.The root cause of the customer's complaint was determined to be a malfunctioning oxygen solenoid valve.

• Brand Name: V60 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 7247330200
• MDR Report Key: 21584608
• Report Number: 2031642-2015-00001
• Device Sequence Number: 9457107
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: (01)00884838009868
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60
• Device Catalogue Number: 1053615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2015
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown