MAUDE Adverse Event Report: UNKNOWN CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problem Wheezing (4463)

Event Type  Injury  

Event Description

Patient was in hospital for 3 days (b)(6) 2024 for observation, per continuous positive airway pressure wasn't working properly.Patient was wheezing.Continuous positive airway pressure was replaced.

• Brand Name: CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18788596
• MDR Text Key: 336474268
• Report Number: MW5152018
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: ACTHAR HP GEL MDV 80U/ML.(B)(6).DOSE:40U.FFREQUENCY: BIW.
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male