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

Model Number V60 V60PLUS VENTILATOR

Device Problems Failure to Power Up (1476); Power Problem (3010)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that the device will not power on.The device was reported to be outside of use at the time of the reported problem.No patient or user harm reported.The customer informed the remote service engineer (rse) that the device powered on itself a couple of times when just the battery was connected.The customer verified that the power supply was getting 120 volts alternating current (ac) but was not getting 24 volts direct current (dc).The rse recommended replacing the power supply and provided the part information.This investigation is ongoing.

Manufacturer Narrative

H10: in a good faith effort (gfe) response from the customer received on 04mar2024, it was stated that the power supply was ordered, delivered, and replaced in the device experiencing the reported issue.The part replacement resolved the issue, and the device was returned to full functionality.The customer stated that the device passed power supply testing, battery testing, and the o2 and air flow rates and pressures were tested.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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18798633
• MDR Text Key: 336643372
• Report Number: 2518422-2024-10357
• 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
• 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 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: 02/20/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/06/2024
• Date Device Manufactured: 12/16/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1