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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Cough (4457)

Event Date 02/01/2022

Event Type  Injury  

Event Description

Severe cough, urgent care visits, several medications, chest x-ray, chest ct scan, dr visits, ent visit, continued severe coughing.Fda safety report id #(b)(4).

• Brand Name: RESPIRINONICS DREAM CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS, INC.
• MDR Report Key: 14513861
• MDR Text Key: 292816685
• Report Number: MW5109921
• 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: 05/20/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2022
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; LOSARTAN ; METOPROLOL ; XARELTO
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White