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

Model Number DSX700H11C

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Began using a philips dreamstation bipap in august 2017.Refer to additional documents in i2k.

• Brand Name: DREAMSTATION BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 17218495
• MDR Text Key: 318137360
• Report Number: MW5118878
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DIABETES MEDICATIONS; HEART MEDICATIONS
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 113 KG