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

Model Number HH1460/00

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

I have been prevented from using my philips dreamstation (a30?) c-pap.The machine only introduces air, and does not allow me to exhale.I have not consulted my physician or equipment provider.Is this an on-going problem which surfaces with these machines? 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: 12835687
• MDR Text Key: 281077156
• Report Number: MW5105433
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00806959025891
• UDI-Public: (01)00806959025891
• 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: 11/16/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: HH1460/00
• Device Catalogue Number: DSX700H11C
• Device Lot Number: 2019-09-24
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; BABY ASPIRIN ; BISOPROLO; CHLORTHALIDONE; FINASTERIDE; FLONASE ; FOCUS FACTOR ; HYDRALAZINE; LANTUS; LARATADINA; LOSARTAN ; METFORMIN ; MORINGA OLEIFERA; MULTIVITAMIN ; OMEPRAZOLE; RYBELSUS; SAW PALMETO ; SILODOSIN; TORSEMIDE; TYLENOL 1,000 MG
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Hispanic
• Patient Race: White