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

Model Number DSX500T11C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Insufficiency (4462)

Event Date 09/01/2021

Event Type  Injury  

Event Description

I was using the philips cpap machine and i was having trouble breathing and very irritated esophagus.It got so bad, i couldn't even breathe laying down.I figured it had to be something with the cpap.Then, i researched online and found that the device had been recalled.Neither philips or the dme contacted me to let me know that the device had been recalled.Went to my lung doctor and my lung capacity was at 68%.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / /RESPIRONICS, INC.
• MDR Report Key: 15651530
• MDR Text Key: 302283679
• Report Number: MW5112773
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025646
• UDI-Public: 00606959025646
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2022
• Patient Sequence Number: 1
• Treatment: CALCIUM; CARVEDILOL ; DAILY VITAMINS; DITROPAN; HIP REPLACEMENT; JANUVIA; LEVYING; LIPITOR ; MAXALT; MICARDIS; NEUROSTIMULATOR IMPLANT; NORVASC; TRULICITY; ZANAFLEX
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White