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 01/02/2024

Event Type  malfunction  

Event Description

Philips received a complaint from customer biomed reporting a proximal pressure sensor autozero failed message occurred on the v60 ventilator.The device was in clinical use.There was no report of harm, nor any adverse outcome to patient care or therapy.The device did not meet specification for intended use and was removed from service.A philips remote service engineer (rse) evaluated the issue with the biomed engineer (bme) and confirmed the reported issue.The bme confirmed the diagnostic code in the device event log, indicating the proximal pressure is not measured and pressure-related alarms are compromised.The rse advised the bme according to the manufacturer's recommendations found in the v60 service manual, which included verifying pin alignment and possible part replacements.The bme requested onsite service for further corrective action.A philips authorized service provider (asp) evaluated the device and confirmed in review of the device event log, the reported issue.The pse reported the issue occurred once and the device continued to function without interruption.The pse determined replacement of data acquisition (da) printed circuit board assembly (pcba) and solenoid valve 3&4 was advised per the v60 service manual.The device was operational and returned to service after the parts were replaced.The investigation concludes that no further action is required at this time.

• 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: 18572624
• MDR Text Key: 333618645
• Report Number: 2518422-2024-04119
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838090996
• UDI-Public: (01)00884838090996
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• 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 Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1138747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/24/2024
• Date Device Manufactured: 02/04/2021
• 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