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

Device Problem Nonstandard Device (1420)

Patient Problems Fatigue (1849); Hypoxia (1918); Dizziness (2194); Low Oxygen Saturation (2477); Unspecified Respiratory Problem (4464)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Identified with sleep apnea by the (b)(6) and prescribed a philips dreamstation cpap on (b)(6) 2011.I have used cpap every night since date of issue.(b)(6) 2019, went to emergency room at (b)(6) hospital for exhaustion and dizziness.Only result was "low oxygen while walking".(b)(6) appt (b)(6) 2020.O2 sat while resting was borderline.O2 dipped to mid/low 80% range while waiting.Prescribed supplemental oxygen at 2lpm at all times including while on cpap.Cpap recall 2021.(b)(6) loans me on current cpap until it is replaced.Replacement issued about a year later in 2022.Numerous tests since 2020 to find cause for low o2 sat.(b)(6) increased o2 prescription to 2-3lpm at rest, 4-5lpm continuous with exertion and 3lpm with cpap.Heart doctor advised me to use as much o2 as needed to maintain 90% saturation impossible with exertion.Can only do very limited activities.(b)(6) 2022 (b)(6) rated me 100% disabled for my lung issues.I personally believe that the defective cpap machine that i used for over 10 years has destroyed my lungs.(shipped back to philips when i received the replacement in 2022).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17309787
• MDR Text Key: 318969767
• Report Number: MW5119310
• 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: Patient
• Type of Report: Initial
• Report Date: 07/01/2023

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2023
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG 1 A DAY.; BENEFIBER 1TSP A DAY.; CRESTOR 5MG 1 A DAY.; FAMOTIDINE 20MG 2 A DAY.; VITAMIN B12 1000MG 1 A DAY.; VITAMIN D 1000 UNITS 1 A DAY.; ZETIA 10MG 1 A DAY.
• Patient Outcome(s): Disability; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White