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

Model Number DSX500H11C

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 i contacted the philips cpap recall site and found my machine has been recalled.I have a conformation code (b)(4).I have not heard from them since.I have had pieces of foam come through the hose at times.I need this machine to sleep and cannot afford to buy a new one philips needs to repair or replace this machine asap.Thanks.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTOCPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12960766
• MDR Text Key: 282035399
• Report Number: MW5105902
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL ; AMLODIPINE BESYLATE; ASPIRIN ; GABAPENTIN ; GLIPIZIDE ; ISOSORBIDE MONONITRATE; LABETALOL; LISINOPRIL ; LORATADINE; MELOXICAM ; METFORMIN ; SIMVASTATIN
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White