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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Sensing Problem (2917)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

Philips received a complaint from customer biomed reporting a machine and proximal pressure sensor failed message occurred on the v60 ventilator.The device was not in clinical use.There was no report of harm.The device was restricted from use.A philips remote service engineer (rse) evaluated the issue with the biomed engineer (bme) and reported the issue occurred after the data acquisition (da) printed circuit board assembly (pcba) was replaced.The rse assisted the customer with device evaluation and confirmed the issue in the device event log.The bme swapped cables, but the issue persisted.The bme confirmed the air and o2 sensors were not registering on the device info screen.The rse advised the bme of the manufacturer's recommendation of replacement of the motor control (mc) to da cable, then if the issue persists, to replace the da pcba.The rse provided the part details for replacement cable.The investigation is ongoing.

Manufacturer Narrative

The customer bme replaced the motor controller (mc)-data acquisition (da) cable and reported the issue continued.No information displayed on the service screen except for the central processing unit (cpu) printed circuit board assembly (pcba).No power supply voltages were displayed on the pneumatics screen.The rse advised the bme multiple pcbas may be the cause of the issue.The bme requested 4th generation power management (pm) pcba be replaced for possible resolution.

Manufacturer Narrative

A philips authorized service provider (asp) evaluated the device and verified the reported issue in review of the device event log.No pcba information or battery information was displayed on service screen.The asp replaced the motor controller (mc) printed circuit board assembly (pcba) and central printed unit (cpu) pcba.After which, the device powered on with no issues.All pcba information was displayed on-screen.The asp successfully completed all performance verification tests per the v60 service manual.The device was operational and returned to service after repairs were completed.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: 18464629
• MDR Text Key: 332500379
• Report Number: 2518422-2024-01125
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Date Device Manufactured: 04/26/2011
• 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