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

Model Number DSX500T11C

Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problems Apnea (1720); Asthma (1726); Emotional Changes (1831); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 04/15/2021

Event Type  Injury  

Event Description

Ongoing respiratory issues; issues dreamstation autocpap serial # (b)(4) after informing dme provider i already had a perfectly functioning device.After constantly requesting to be provided a return label to ship device back to vendor i was told to try using.Reluctantly after using the device a couple of times i started experience more frequent asthmatic episodes, in addition to being rushed to the er on more than three occasions.After being hospitalized for difficulty breathing i received notice from my doctor indicating a recall on certain cpap machines.After checking it was discovered that the new device was listed and i discontinued use immediately.My respiratory condition is still effected by the use of this machine and has resulted in a lower quality of life for me in addition to the inability to do normal activities i use to be able to do perfectly prior to using this device.I am now also placed on hard copd medications and my job has also been effected to the point i can barely perform duties i was hired to do.I can authorize your office to accept my medical records associated with my condition and how it has gotten worse after the use of this device.I am still suffering daily.Therapy dates: (b)(6) 2021.Reason for use: sleep apnea.Did the problem stop after the person reduced?: no; did the problem return if the person started? yes.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12829681
• MDR Text Key: 281014350
• Report Number: MW5105392
• 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: 11/15/2021

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: Lay User/Patient
• Device Model Number: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2021
• Patient Sequence Number: 1
• Treatment: ALBUTEROL; FASENRA; FLONASE; SYMBICORT
• Patient Outcome(s): Disability; Other; Hospitalization; Required Intervention; Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American