MAUDE Adverse Event Report: RESPIRONICS, INC. V60 PLUS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Device Problems Defective Alarm (1014); Device Sensing Problem (2917)

Patient Problem Increased Respiratory Rate (2486)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Patient was brought up from the emergency department on a v60 plus bipap machine.Once patient arrived to ccu, the emergency department rt stated the proximal pressure sensor alarm had begun to sound.The emergency department rt changed to proximity line, but this did not help.Once nurse arrived at patient's room, it was noticed as an equipment malfunction alarm and not something we would be able to troubleshoot ourselves.A new v60 was brought to patient's room and the patient was placed on new machine.The patient experienced an increased work of breathing along with an increased respiratory rate.

• Brand Name: V60 PLUS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15206
• MDR Report Key: 16875726
• MDR Text Key: 314628924
• Report Number: 16875726
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023,11/30/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Female
• Patient Race: White