MAUDE Adverse Event Report: PHILLIPS / RESPIRONICS INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900S11

Patient Problems High Blood Pressure/ Hypertension (1908); Sleep Dysfunction (2517); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/11/2024

Event Type  malfunction  

Event Description

Using replacement/rebuilt autosv bi-pap phillips and noticed that filters in the last month are coming out almost black when replacing the filters routinely.Normally, the filter is not noticeably dirty when being replaced.This happened on my original system as well prior to replacement where the replacement filter which is changed out bi-weekly is almost black for no known cause or a cause i can identify with doctor's assistance.Benign cramp fasciculation muscle/nerve disorder, obstructed/central sleep apnea, hypersomnia, morton's neuroma both feet, high blood pressure.Refer to additional documents in i2k.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILLIPS / RESPIRONICS INC.
• MDR Report Key: 18902354
• MDR Text Key: 337845264
• Report Number: MW5152820
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• 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: 03/11/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2022
• Device Model Number: DSX900S11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2024
• Patient Sequence Number: 1
• Treatment: ALSO, HAVE A SPINAL STIMULATOR FOR THE LAST YEAR.; APPLE VINEGAR.; ASPIRIN.; BACLOFEN.; CANDESARTAN.; CLONAZEPAM.; D-AMPHETAMINE.; FISH OIL. ; GARLIC.; MAGNESIUM GLYCINATE.; MAGNESIUM MALATE, MAGNESIUM GLYCINATE, ZINC, FISH OIL, VITAMIN D, MULTI VITAMIN, MELATONIN, ASPIRIN, GARLIC, APPLE VINEGAR.; MELATONIN.; MULTI VITAMIN.; NABUMETON.; ROPINIROLE.; TOPIRAMATE.; VITAMIN D.; ZINC.
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White