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

Device Problem Insufficient Information (3190)

Patient Problem Pneumonia (2011)

Event Date 11/16/2021

Event Type  Injury  

Event Description

Caught pneumonia.Fda safety report id # (b)(4).

Event Description

Caught pneumonia.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 13472549
• MDR Text Key: 285267252
• Report Number: MW5107235
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 1414888 DEMADEX(TORSEMIDE); 1438523 IPRAT-ALBUT 1393074 NORCO; 1443304 TRELEGY ELLIPTA ; CANE LOTREL(AMLODIPINE-BENAZEPRIL 1443305 ; LIPTOR(ATORVASTATIN) 1421768 ; MEBULIZER; MELOXICAM (MOBIC) 1428572 ; MENS MULTI VITAMIN ; OXYGEN; PROTONIX 1431611 METOPROLOL (TOPROL XL) ; TYLENOL ARTHITIS
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White