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 04/15/2024

Event Type  malfunction  

Manufacturer Narrative

G1 contact office phone: (b)(6).

Event Description

Philips received a complaint on the v60 ventilator, indicating that there was a proximal pressure sensor autozero failed alarm.The device was reported to be in use at the time of the reported problem.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.This investigation is ongoing.

Manufacturer Narrative

H10: in a good faith effort (gfe) response from the customer received on 01may2024, it was stated that the customer had made the decision to pull the ventilator which experienced the autozero alarm from service.The customer was unsure if the repair would be completed in the future, if the device would be traded in, or discarded.No further work was performed by philips to resolve the issue.The customer did not provide the patient information in the gfe response received on 01may2024.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19137096
• MDR Text Key: 340869215
• Report Number: 2518422-2024-20770
• 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,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

• Date FDA Received: 04/18/2024
• 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
• Date Manufacturer Received: 05/01/2024
• Date Device Manufactured: 09/10/2013
• 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