MAUDE Adverse Event Report: EMERGENT CPAP OS

Model Number CPAP OS

Device Problem Pressure Problem (3012)

Patient Problem Respiratory Distress (2045)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

Patient was found in moderate/severe respiratory distress.The cpap unit was applied to the patient.Crew members state the unit sounded like it was leaking air.They tightened the oxygen tubing and the unit seemed to be working fine.During transport of the patient unit began to sound like it did not have a good mask to face seal.They confirmed that the face mask was applied appropriately and the patient complained about not getting enough air.The crew then noticed that the pressure gauge on the unit was too high, and they were unable to adjust the pressure down to normal operating ranges.The cpap unit was removed from the patient and a different unit was placed on the patient that worked appropriately.Date: (b)(6) 2015.

• Brand Name: CPAP OS
• Type of Device: CPAP
• Manufacturer (Section D): EMERGENT; carlsbad CA 92010
• MDR Report Key: 4667567
• MDR Text Key: 5609405
• Report Number: MW5041955
• Device Sequence Number: 1
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CPAP OS
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 75