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

Model Number V60

Device Problem Failure to Sense (1559)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator was unavailable due to the device not alarming when the patient was disconnected from the device.The device was in clinical use when the issue occurred.There was no patient or user harm reported.The customer reported that when the tube set was removed, the device did not alarm.The biomedical engineer (bme) evaluated the device and confirmed that the device would alarm (patient disconnect) every time the tube set was removed from the device.Per the bme, the reported issue could not be duplicated.The customer requested that the device be evaluated to determine if it¿s ready for use.The device was sent to bench repair.

Manufacturer Narrative

A service engineer (se) evaluated the device and reported that the issue could not be duplicated.The se reported that the device was tested for many days, and the device always alarmed for the patient disconnect when disconnected.

Manufacturer Narrative

There was no medical intervention or delay in therapy reported.The customer provided additional patient information (a2 and a4).

• 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: 18609341
• MDR Text Key: 334118239
• Report Number: 2518422-2024-05089
• 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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/20/2024; 02/28/2024
• Supplement Dates FDA Received: 02/22/2024; 03/07/2024
• Date Device Manufactured: 08/02/2016
• 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
• Patient Age: 73 YR
• Patient Weight: 56 KG