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

Model Number V60

Device Problem Inadequate User Interface (2958)

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

Event Date 04/22/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer on the v60 device indicating that while performing preventative maintenance, there is misalignment in the touch position.There was no patient involvement at the time the issue was discovered.There was no report of patient or user harm.An authorized service provider (asp) evaluated the device and confirmed the reported problem.Since the touch position misalignment was not resolved by calibrating the touchscreen, the touchscreen was replaced to resolve the reported issue.The device passed the required performance verification tests per philips standards and was returned to service.

Manufacturer Narrative

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

• 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: 19218235
• MDR Text Key: 341466102
• Report Number: 2518422-2024-24080
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare 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: Other
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/30/2024
• Date Device Manufactured: 10/30/2017
• 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