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

Model Number DSX500S11X

Device Problems No Display/Image (1183); Noise, Audible (3273); Key or Button Unresponsive/not Working (4063)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

Philips replaced my cpap under the recall.I got one day out of the replacement before the replacement stopped working.It just has a blank screen and beeps.The power button doesn't work nor does the ramp button.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION.
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR).
• Manufacturer (Section D): PHILIPS /RESPIRONICS INC.
• MDR Report Key: 13798516
• MDR Text Key: 287433037
• Report Number: MW5108217
• Device Sequence Number: 2
• 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: 03/14/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11X
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEXAPRO.
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White