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

Model Number V60

Device Problem Device Sensing Problem (2917)

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

Event Date 04/16/2024

Event Type  malfunction  

Manufacturer Narrative

G: phone: (b)(4).

Event Description

Philips received a complaint from the service engineer, reporting that the v60 ventilator displayed the following error code - check vent: proximal pressure sensor auto-zero failed".There was no patient involvement when the issue occurred.No patient or user harm reported.A philips service engineer (se) noted that while reviewing the event log, the occurrence of a "check vent: proximal pressure sensor auto-zero failed" was observed/confirmed.The se then noted that the solenoid valves (3 and 4) were replaced to resolve the issue.This concludes the investigation.Issue will be tracked and trended.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19195700
• MDR Text Key: 341238826
• Report Number: 2518422-2024-22920
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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: 1076709
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/26/2024
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1