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

Model Number V60

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

E1 reporting institution phone number - (b)(6).Reporter phone number - (b)(6).

Event Description

Philips received a complaint on the v60 ventilator indicating that there was a vertical stripe appearing on the device¿s monitor.The device was reported to be outside of use at the time of the reported problem.There was no patient or user harm reported.A remote service engineer spoke with the customer who communicated the device issue but stated that the touchscreen was working.A field service engineer (fse) went to the customer¿s site and replaced the 2nd generation liquid crystal display (lcd) to resolve the vertical stripe issue.The fse completed a performance verification test (pvt), which the device passed.The device was returned to the customer ready for clinical use.

• 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: 18874713
• MDR Text Key: 337321015
• Report Number: 2518422-2024-13144
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: 00884838009868
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 1053615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/11/2024
• Date Device Manufactured: 05/22/2015
• 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