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

Model Number V60 V60PLUS VENTILATOR

Device Problem Unstable (1667)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator came off the stand.There was no patient involvement when the issue occurred.No patient or user harm reported.

Manufacturer Narrative

H10: the customer reported that the issue was resolved after adjusting the screws at the bottom of the device, to the base of the roll stand.The device was returned to service.

• 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: 18749565
• MDR Text Key: 336096557
• Report Number: 2518422-2024-08883
• 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: 02/14/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/11/2024
• Date Device Manufactured: 05/14/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1