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

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problems Irritability (2421); Cough (4457)

Event Date 05/28/2023

Event Type  malfunction  

Event Description

I was among the first to register for the philips cpap recall.The last 2 years before the recall, i had been suffering constant throat irritation and coughing.After waiting more than 2 years (!), i finally received the replacement last week.Trying it for 2.5 nights, i suffered exactly the same symptoms as with the original unit (have now stopped).Switching to the (different brand) replacement i had bought earlier, the symptoms went away almost immediately.Something is very wrong with the philips replacement units!!! reference report: mw5118107.

• Brand Name: DREAMSTATION AUTOCPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17057663
• MDR Text Key: 316639205
• Report Number: MW5118106
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LISINOPRIL, AMLODIPINE, SYNTHROID, ALLOPURINOL, FAMOTIDINE.
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White