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

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2022

Event Type  malfunction  

Event Description

I have been on the recall list for a new philips respironics dreamstation for 15 months.I received what is supposed to be their replacement machine yesterday.This machine is supposedly refurbished.The paperwork included in the box states it has been cleaned and sanitized.This is simply not true.The screen on the machine is dirty, and when i opened one of the flaps on the side, a hair fell out.This alone tells me they did nothing to clean and sanitize a machine that someone else has been breathing into.It's disgusting, sending out used machines to people is unacceptable.There are people that received brand new machines as their replacements early on.And the rest of us are now receiving the junk that was returned to philips from the recall.We should all be receiving brand new machines.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTOCPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS INC.
• MDR Report Key: 15499261
• MDR Text Key: 300897861
• Report Number: MW5112315
• 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: 09/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White