MAUDE Adverse Event Report: RESPIRONICS INC. AF531 EE LEAK 1 4 PT HDG, SU, SINGLE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Catalog Number 1119008

Device Problem Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

Event Description

Reported the exhalation valve broken on the patient's mask and sats decreased to 77-80%.Water had accumulated in the mask, due to the heated mode of therapy and the patient running a fan on the mask.The water settled in the exhalation valve and did not read the pressure correctly on the machine.Oxygen sats were 96% when i arrived to the room.Pt stated her breathing was better (prior to the mask being changed).The pt had the same mask on for the past couple of days.Respiratory therapist team lead changed the mask when she noticed the excessive water.Exhalation valve was not broke; instead, water needed to be emptied from the mask.No adverse reactions to the pt.

• Brand Name: AF531 EE LEAK 1 4 PT HDG, SU, SINGLE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 8639693
• MDR Text Key: 146047467
• Report Number: 8639693
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2019,02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1119008
• Device Lot Number: 180626
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Weight: 73