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

Model Number V60

Device Problems Obstruction of Flow (2423); Blocked Connection (2888)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

While in clinical use, the device had patient circuit occluded message.No reports of patient/user harm,/injury.Investigation is ongoing.

Manufacturer Narrative

H10: philips received a complaint from the customer, reporting that the v60 ventilator displayed a patient circuit occluded message.The device was in clinical use when the issue occurred; the device was removed from service.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer reported that the device was displaying error code 1134 (blower stalled), and patient circuit occluded.During troubleshooting, it was observed that the device was in service mode when attempting to adjust pressure on device; it was then noted that the rpm for blower stayed at 3000, and never adjusting with pressure.The rse confirmed that the event log documented error code 1134.The rse recommended replacing the blower assembly.The customer was provided with the blower part id.The customer reported that the blower assembly was replaced, and the issue was resolved.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: 16921632
• MDR Text Key: 315123889
• Report Number: 2518422-2023-11064
• 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
• 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 Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/18/2023
• Date Device Manufactured: 12/11/2012
• 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