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

Model Number V60

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the device is draining o2 tank while attached to wall o2.It was reported there was no patient involvement at the time the issue was discovered.There was no patient or user harmed.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The rse provided the customer instructions on checking the o2 solenoid valve.The customer informed that the o2 flow remained the same with or without o2 connected.He also mentioned that he was unable to duplicate problem.Respiratory created a request with that complaint.The customer was instructed to run the unit in ventilation mode with 21% o2 and check the o2% with the certifier.If the device fails, it was recommended to replace the o2 solenoid valve.If it passed, then the entire performance verification testing has to be performed.The customer stated everything is passing, and he could not duplicate any issue with the o2 solenoid valve.The customer states he will finish testing device and return device back to use if no further issues are found.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17845684
• MDR Text Key: 324617379
• Report Number: 2518422-2023-25039
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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 Operator: Other
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 09/29/2023
• Date Device Manufactured: 10/21/2015
• 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