MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. CPAP DREAM STATION GO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Nonstandard Device (1420)

Patient Problems Asthma (1726); Unspecified Heart Problem (4454)

Event Type  Injury  

Event Description

For a year and a half i have been trying to get a replacement for a respironics travel cpap.I reported months ago that i have a heart condition and asthma that makes cpap absolutely necessary.I have been shuffled from one office to another.I have been communicating for weeks that i am travelling out of the country for several weeks and need to machine.All i get is a run around.Since travel is early in january, you would have to act fast to be of help to me.Regardless i think respironics has to be held accountable for what will undoubtedly be further delays for all customers.Non smoker.The issue is that respironics has not responded in acceptable way even when told of conditions that make use of cpap essential even when traveling.

• Brand Name: CPAP DREAM STATION GO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 16094565
• MDR Text Key: 306696739
• Report Number: MW5114141
• 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: 12/29/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2023
• Patient Sequence Number: 1
• Treatment: "NM"; DIGOXIN ; PROPATHANINE; XERALTO
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White