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

Model Number V60

Device Problem No Display/Image (1183)

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

Event Date 04/11/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the biomedical engineer (bme) on the v60 ventilator indicating that when the device turned on, the display was blank.There was no patient involvement at the time the issue was discovered.There was report of patient or user harm.A remote service engineer (rse) discussed first-generation versus second-generation liquid crystal display (lcd) user interface (ui) assembly with the bme and provided the part number for the second-generation ui assembly.The rse also advised the bme to make sure that the device has 2.1 software or higher for compatibility.

Manufacturer Narrative

Per good faith effort (gfe) response, the bme installed the nec display but had a hard time with upgrading the software version that was required.Multiple attempts have been made to try to obtain further information about this case, 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19185779
• MDR Text Key: 341164162
• Report Number: 2518422-2024-22572
• 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

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: Other
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/10/2024
• Date Device Manufactured: 06/09/2011
• 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