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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Sense (1559)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

E1: reporter information: (b)(6).

Event Description

Philips received a complaint from the customer, reporting a machine pressure sensor autozero failed message occurred on the v60 ventilator.The device usage at the time of the event was not provided.There was no report of harm, or other patient impact.The customer biomedical engineer (bme) performed a power cycle and reported there was no recurrence of the issue.The device remained in service until the issue was reported to manufacturer's sales representative (msr).At that time, the device was removed from service for further evaluation.The msr confirmed the issue in the device event log but was unable to replicate the reported problem.The investigation is ongoing.

Manufacturer Narrative

H10: the device was in clinical use.There was no report of harm, or other patient impact.A manufacturer's product support engineer (pse) evaluated the device and was unable to reproduce the reported error during testing.However, an occurrence of check vent: machine pressure sensor auto zero failed message (diagnostic code: 1109) was confirmed in the device event log.The pse replaced the solenoid valves to resolve the issue.The device was operational and returned to service after repairs were completed.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: 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: 19018591
• MDR Text Key: 339095905
• Report Number: 2518422-2024-16794
• 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,User Facility
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Date Device Manufactured: 07/06/2017
• 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