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

Model Number V60

Device Problem Gas Output Problem (1266)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that a "low leak co2 rebreathing risk" alarm occurred during s/t testing in normal ventilation while performance verification testing (pvt) was performed.It was reported that there was no patient involvement at the time the issue was discovered.The customer requested troubleshooting and reported to the remote service engineer (rse) that a "low leak co2 rebreathing risk" alarm occurred during s/t testing in normal ventilation while performance verification testing (pvt) was performed.The customer informed the rse that following a flow sensor assembly replacement, the customer heard the o2 leaking.The rse went through the customer's setup and found that the customer did not replace the o-ring with the flow sensor assembly.The customer planned to replace the o-ring and perform further testing.Additionally, the customer called back, and another rse advised the customer of the correct setup per revision r and noted that the whisper swivel was missing.The customer installed the whisper swivel, and the device cycled normally without alarming.

• 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: 16522301
• MDR Text Key: 311067872
• Report Number: 2518422-2023-06624
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,User Facility
• Reporter Occupation: Biomedical Engineer
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2017
• 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