MAUDE Adverse Event Report: PHILLIPS RESPIRONICS / RESPIRONICS, INC. RESPIRONICS BIPAP AUTO, SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number SYSTEM ONE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Asthma (1726); Bacterial Infection (1735); Dyspnea (1816); Muscle Weakness (1967); Pneumothorax (2012); Weight Changes (2607); Tissue Breakdown (2681); Cough (4457)

Event Date 10/31/2016

Event Type  Injury  

Event Description

I was sold a respironics system one bipap auto with humidifier by sleep technologies on (b)(6) 2016.I have religiously used it every night.I now have a partially collapsed right lower lung, persistent cough for 4 plus months, sores periodically on my nostrils, sinus congestion/infections, sob severely limiting walking, weight gain, weakness, asthma (newly dx by pulmonologist), possible heart issues (still being evaluated).I purchased the soclean system approximately 1-2 years ago and use it daily in a well ventilated large room as a method of cleaning.The atelectasis was recently diagnosed via chest ct, i realized that i have had a slight crinkling sound during breathing as long as two or three years ago which is intermittent and absent presently.The sinus congestion/infections have been going on for over four years.The sob has started within the last five years but has become extreme in the last four months prompting significant medical testing.I have walked for exercise 5-6 times per week for decades often going 3-4 miles per walk but since the severe shortness of breath i have been hardly able to walk a mile, needing frequent rests to catch my breath.Recently i started monitoring my walks with a pulse ox.On more than one occasion, after going only 1/8th of a mile, my ox dropped to 89 but paradoxically my pulse was only 55 despite severe huffing and puffing.Yet as soon as i stopped and sat down my pulse jumped to 129 and my ox sat rate slowly recovered to 96 within 1 or 2 minutes.This has severely and adversely effected my overall health.My sob is significantly worse when i try to garden or bend over.Fda safety report id# (b)(4).

• Brand Name: RESPIRONICS BIPAP AUTO, SYSTEM ONE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILLIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 12180621
• MDR Text Key: 262216877
• Report Number: MW5102576
• Device Sequence Number: 1
• Product Code: MNS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYSTEM ONE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR
• Patient Weight: 139