MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION AUTO CPAP DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500S11F

Patient Problems Apnea (1720); Unspecified Blood or Lymphatic problem (4434); Unspecified Respiratory Problem (4464); Dry Mouth (4485)

Event Type  Injury  

Event Description

Family member with osa(obstructive sleep apnea) received replacement recertified dreamstation cpap unit (b)(6) 2022.Has had normal cbc(complete blood count) previously.Four months after receiving different unit, he developed erythrocytosis felt to be secondary due to osa.Has been having issues with pressure regulation and dry inflamed oral mucus membranes in spite of several adjustments to the machine and hose replacement.The dme company checked the unit but felt the machine was functioning properly.The previous unit did not cause any of these symptoms.Also he has not been able to be compliant with usage because of what's been going on.

• Brand Name: DREAMSTATION AUTO CPAP DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18667715
• MDR Text Key: 335069211
• Report Number: MW5151165
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11F
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BABY ASA,; BUSPAR; COQ10; CRESTOR; ELIQUIST; FLONASE; GLUCOSAMINE CHRONDROITIN ; GLUCOTRUST; HEMP; JARDIANCE; LEVOXYL; LOTENSIN; MELATONIN ; METOPROLOL; PROBIOTIC; TURMERIC; TYLENOL; ZOLOFT
• Patient Outcome(s): Disability
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White