MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS, INC. PHILIPS RESPIRONICS SYSTEM ONE CPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number REM STAR AUTO DOM 560P

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Dizziness (2194); Discomfort (2330)

Event Date 04/27/2015

Event Type  Injury  

Event Description

In mid (b)(6) 2015, i was having symptoms of an ear or sinus infection.Seeking some solutions on my own, i purchased a new cpap to see if perhaps it was contributing to the issue.I received the new phillips cpap on or about the (b)(6) 2015 and symptoms grew worse.My symptoms were bad enough to go to the doctor and to have my doctor sign a "do not fly" order which resulted in my being temporarily disabled (collecting disability) i continue to have symptoms, have gone to an ent and have my ears and throat checked each time i go to the doctor.I have since retired as i was no longer willing to put my body through the extreme discomfort of flying and all of the stress related to the process of decompression and compression with flying.Though i am not disabled, i do suffer recurring (every other day) feeling of fullness and in dizziness in my head for which there has been no explanation.With this current recall, i am eagerly awaiting the opportunity to try a different cpap machine to determine if this is the source of my ongoing discomfort.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS SYSTEM ONE CPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 12049561
• MDR Text Key: 258069473
• Report Number: MW5102021
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REM STAR AUTO DOM 560P
• 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: 57 YR
• Patient Weight: 92