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

Model Number V60

Device Problem Failure to Sense (1559)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer biomed reporting a proximal sensor autozero failure message intermittently occurs on the v60 ventilator.The device was not in clinical use.There was no report of harm not other impact to patient or user/ the device was removed from service and submitted for an evaluation.A philips remote service engineer (rse) evaluated the issue with the biomed engineer (bme) and confirmed the issue was confirmed in the device event log.The bme reports the issue cannot be duplicated in testing.The bme requested the device be submitted for evaluation by bench repair.

Manufacturer Narrative

H10: a manufacturer's product support engineer (pse) evaluated the device and confirmed in the event log the diagnostic code indicating a proximal pressure sensor autozero failed error had occurred.The pse determined component replacement was necessary to fix problem.The solenoid valve three and four were replaced.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: 18545623
• MDR Text Key: 333273351
• Report Number: 2518422-2024-03562
• 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
• Device Catalogue Number: 1138747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/01/2024
• Date Device Manufactured: 11/30/2020
• 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