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

Model Number V60 V60PLUS VENTILATOR

Device Problem Display Difficult to Read (1181)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that the display was dim.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.The device was removed from service, but there was no reported impact to the patient.The biomedical engineer (bme) called technical support to report that the display was dim and confirmed that the device had a first generation hydis display.The remote service engineer (rse) advised the bme of the six parts that can be ordered to upgrade from a first generation hydis display to a second-generation nec display.Investigation ongoing.

Manufacturer Narrative

H10 per good faith effort (gfe) response, there was no patient involvement at the time the issue was discovered as the issue occurred during setup, and the device was replaced with another ventilator.The bme has not received a quote to upgrade from a first generation hydis display to a second-generation nec display.Repair is still pending.

Manufacturer Narrative

Per follow-up good faith effort (gfe) response, the bme stated that parts were ordered to upgrade the display.The bme called technical support again to inquire about the availability of the second-generation ui assembly as the device failed performance verification testing (pvt).The rse therefore provided the bme with the part number, price, and current availability of the gray ui assembly.Multiple attempts have been made to try to obtain further information regarding the repair and whether the device has been returned to service, but no response was received from the bme.This file is closed and can be reopened if new information becomes available.

• 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: 18839683
• MDR Text Key: 336971889
• Report Number: 2518422-2024-11811
• 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: Biomedical Engineer
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/08/2024; 04/25/2024
• Supplement Dates FDA Received: 03/20/2024; 05/01/2024
• Date Device Manufactured: 11/19/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1