MAUDE Adverse Event Report: Respironics, Inc. Respironics; Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Model Number	V60 V60Plus Ventilator
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the v60 ventilator stand had a broken locking caster.There was no patient involvement when the issue occurred.No patient impact and/or harm was reported.No user impact and/or harm was reported.A philips remote service engineer (rse) provided assistance to the bme, and it was reported that the issue was replicated during diagnostics.The bme was provided with the part numbers (locking casters, and caster wrench) for replacement parts.The issue was replicated/confirmed during diagnostics.Based on the details provided, the damaged castors are considered a malfunction and can become a stability issue for the device.This investigation is ongoing.
Additional Manufacturer Narrative
A follow up was performed with the customer, and it was reported that the casters were replaced to resolve the issue.The device was reported to have been returned to service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The cause of the broken locking caster could not be determined; the customer did not provide any further details regarding the event.A conclusion/root cause cannot be provided, as the suspected part has not been returned for further analysis.

• Brand Name: Respironics
• Common Device Name: 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 ; +1(724)733-0200
• MDR Report Key: 50931993
• Report Number: 2518422-2026-115483
• Device Sequence Number: 10725387
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Other
• Device Model Number: V60 V60Plus Ventilator
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 08/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown