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 02/02/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the error code, "the proximal pressure is not measured and pressure-related alarms are compromised" (diagnostic code 110b) had occurred.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.The customer called in to report that the error code, "the proximal pressure is not measured and pressure-related alarms are compromised", had occurred.The remote service engineer (rse) and customer performed a troubleshoot of the v60.The rse referenced the service manual and provided troubleshoot steps from the service manual.The rse then provided the part number for the solenoid valve and data acquisition (da) printed circuit board assembly (pcba), the investigation is ongoing.

Manufacturer Narrative

The customer called in to report that the error code, "the proximal pressure is not measured and pressure-related alarms are compromised", had occurred.The remote service engineer (rse) and customer performed a troubleshoot of the v60.The rse referenced the service manual and provided troubleshoot steps from the service manual.The rse then provided the part number for the solenoid valves and data acquisition (da) printed circuit board assembly (pcba), the customer replaced the solenoid valves and da pcba but reported that the issue was not resolved.The rse emailed the customer a bench repair form for further evaluation of the device.At bench repair, the reported issue had been confirmed.Bench repair then reconnected the da pcba and confirmed the reported issue had been confirmed.Bench repair reconnected the da pcba to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.The investigation concludes that no further action is required at this time.

Manufacturer Narrative

The customer replaced the solenoid valves and da pcba but reported that the issue was not resolved.The rse emailed the customer a bench repair form for further evaluation of the device.Device evaluation and repair are pending.

• 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: 18696554
• MDR Text Key: 335261356
• Report Number: 2518422-2024-07117
• 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: Followup,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 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/22/2024; 04/03/2024
• Supplement Dates FDA Received: 02/27/2024; 04/05/2024
• Date Device Manufactured: 08/08/2018
• 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