MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. SYSTEM ONE / REMSTAR AUTO A- FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number SYSTEM ONE

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Dyspnea (1816); Fever (1858); Pain (1994); Burning Sensation (2146); Discomfort (2330); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

For no reason i began to feel congestion and short of breath, no cough, no phlegm, no fever, nasal irritation, pain and discomfort with burning center of chest.Had multiple negative covid tests.Still have symptoms, wife said that the cpap was making me sick.I did notice black residue floating things in the water when i cleaned the hose and face mask.Never used commercial cleaner.Have been seen by (4) doctors to date.I do have the cpap machine.Many tests.At this time it is not known why i have difficulty with breathing, sore throat, nasal congestion, pain with respiration.Fda safety report id# (b)(4).

• Brand Name: SYSTEM ONE / REMSTAR AUTO A- FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12665100
• MDR Text Key: 277869011
• Report Number: MW5104772
• Device Sequence Number: 1
• Product Code: BZD
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SYSTEM ONE
• Device Catalogue Number: REV01
• Device Lot Number: 560P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Weight: 77