MAUDE Adverse Event Report: RESPIRONICS, INC. V60 V60PLUS VENTILATOR; 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 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Philips received a complaint on the v60 ventilator indicating there was a proximal pressure sensor autozero issue.The device was reported to be outside of use at the time of the reported problem.No patient or user harm reported.This investigation is ongoing.

Manufacturer Narrative

Philips received a complaint on the v60 ventilator indicating that there was a proximal pressure sensor autozero issue.We are unable to confirm the alleged device issue or final disposition of the device because the customer allowed the quote for onsite service to expire, refusing service.No further work was performed by philips.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: V60 V60PLUS VENTILATOR
• 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: 18974250
• MDR Text Key: 338573107
• Report Number: 2518422-2024-15089
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• 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
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/10/2024
• Date Device Manufactured: 04/02/2021
• 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