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

Model Number V60

Device Problem Failure to Sense (1559)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that there was a proximal pressure sensor auto zero failed alarm.The device was reported to be outside of use at the time of the reported problem.There was no patient or user harm reported.The remote service engineer (rse) informed the customer to perform the following troubleshooting steps in this order: verify the pin alignment between the solenoids and data acquisition (da) printed circuit board assembly (pcba), replace the 3rd and 4th proximal autozero solenoids, and then replace the da pcba.

Manufacturer Narrative

In a good faith effort (gfe) response received from the customer, it was stated that the customer did not order any replacement part following the remote service because it was found that the solenoid pins were not lined up.Following the reseating of the data acquisition board, the device was put back into use.

• 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: 18925010
• MDR Text Key: 337918637
• Report Number: 2518422-2024-14212
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: 03/01/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/28/2024
• Date Device Manufactured: 11/30/2017
• 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