MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC V60 RESPIRONICS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Device Problem Noise, Audible (3273)

Patient Problems Bacterial Infection (1735); Dyspnea (1816); Aspiration Pneumonitis (4455)

Event Date 08/21/2021

Event Type  Death  

Event Description

On (b)(6) 2021, my wife (b)(6) was a patient at (b)(6) hospital located on the 4th floor of (b)(6) hospital (b)(6).She began having breathing problems.I asked the duty nurse to transfer her to the er located next door or to the icu located on the 7th floor.I was told that because she was in a critical unit they did not transfer patients from one critical care unit to another.I asked to see the hospitalist on duty.She came and directed my wife to have x-rays.From my chart i read that my wife had bacterial and aspiration pneumonia.She was immediately placed on antibiotics and given ativan for pain.On sunday morning (b)(6) her breathing problems worsen.(b)(6) recommended that i make my wife comfortable by placing her on a ventilator.She was immediately placed on a phillips v60 respironics ventilator.For a brief time she seemed to be breathing fine.As the evening and night approach her breathing again was difficult.The duty respiratory techs made adjustments to the oxygen by increasing it as they thought was appropriate.A dr.(b)(6) suggested she be given morphine to help her pain.I was sitting at her bedside holding her arm and half asleep when i woke up to the male respiratory techs making an adjustment to the ventilator.That was approximately 3 am.He did not say a word to me just touched my shoulders and walked out.Approximately 30 minutes later the ventilators made a loud buzzing noise and i check my wife and she was no longer breathing.I immediately ask the female what did that guy do, she informed me that he had turned the oxygen down.I ask why did he do that when he knew she needed that oxygen.No answer was given.Earlier in the evening i had asked the female respiratory tech why was my wife placed on a ventilator that had been recalled.She told me the lower part shown on the photo was the recalled part and it was not being used.My request of the fda is the phillips v60 respironics ventilator shown used on my wife a recalled unit? if so, my wife passed from it's use at the hands of (b)(6) hospital doctors and respiratory techs.

• Brand Name: V60 RESPIRONICS VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC
• MDR Report Key: 12744791
• MDR Text Key: 280080133
• Report Number: MW5105083
• Device Sequence Number: 1
• Product Code: MNT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/02/2021

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death