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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Sense (1559)

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

Event Date 01/26/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator displayed a "proximal sensor pressure auto zero failed" error code.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's.During troubleshooting, the customer confirmed the issue, and reported that the event log had a 110a error code (proximal pressure sensor autozero failed).The rse provided the recommended repair per the manufacturer's recommendations; verify pin alignment between solenoids and the data acquisition (da) board, replace the proximal auto-zero solenoid (sol 3 and sol 4), replace the da board.The customer was provided with the part numbers for replacement parts.The investigation is ongoing.

Manufacturer Narrative

A follow up was performed with the customer, and it was reported that during the evaluation of the device, it was observed that the solenoid valves were not seated properly.The customer reported that the issue was resolved after reseating the solenoid valve.It was reported that the device has been working as intended.

• 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: 18686323
• MDR Text Key: 335138056
• Report Number: 2518422-2024-06899
• Device Sequence Number: 1
• Product Code: MNT
• 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,User Facility
• 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: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/17/2024
• Date Device Manufactured: 01/28/2020
• 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