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

Model Number V60

Device Problem No Flow (2991)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that device presents several alarms and will not turn off while on a patient.There was no harm to the patient or user.No medical intervention provided to the patient, nor a delay was noted.

Manufacturer Narrative

A field service engineer (fse) went on site to complete a full performance test to find any issues that may have caused the reported problem.It was observed that the failure in this case was a 35v failure based off the diagnostics report (drpt) provided.This failure would cause the devices touchscreen to freeze and alarms to uninitiate and have power failure.The following parts were observed to be bad that needs replaced; pm pcba board; cpu pcba board and mc pcba board.The fse ordered all parts to be replaced to resolve the reported problem.

Manufacturer Narrative

The field service engineer (fse) replaced the motor controller board, central processing unit board, and power supply to resolve the reported issue.The device passed the required performance verification tests per philips standards and was returned to service.

• 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: 17990093
• MDR Text Key: 326324929
• Report Number: 2518422-2023-27615
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: Other
• Type of Report: Initial,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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 12/18/2023; 01/31/2024
• Supplement Dates FDA Received: 12/20/2023; 02/13/2024
• Date Device Manufactured: 11/19/2014
• 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