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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemoptysis (1887); Vomiting (2144); Choking (2464)

Event Date 01/01/1990

Event Type  Injury  

Event Description

Spitting up blood, choking in morning, mucus so bad he throws up.Started philips cpap machine in 1990's and started having all these negative symptoms in 2003.

• Brand Name: PHILIPS CPAP BREATHING MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13289635
• MDR Text Key: 284147446
• Report Number: MW5106744
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: B-13 FOR WEIGHT LOSS; CARVEDILOL ; PANTOPRAZOLE ; XARELTO
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Disability; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 159 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American