MAUDE Adverse Event Report: RESPIRONICS, INC. AF531 EE LEAK1; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1072629

Device Problem Mechanical Problem (1384)

Patient Problem Hypoxia (1918)

Event Date 02/16/2021

Event Type  Injury  

Event Description

The manufacturer was made aware of an event occurring while an (b)(4) mask was in use.A covid+ patient was placed on bi-level positive airway pressure (bipap) ventilation 2 days before the event.The patient reportedly rolled over in bed, dislodging the mask from the bipap circuit, and decompensated immediately, resulting in the need for bagging to correct hypoxemia.The mask was then reconnected and niv was reinstituted.The mask is not available for investigation.The (b)(4) leak 1 face mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single use in the hospital/institutional environment only.The mask is to be used on patients (>30 kg) for whom cpap or bi-level therapy has been prescribed.Labeling warns the caregiver "this mask is not suitable for providing life support ventilation.This mask should not be used for patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask.Appropriate patient monitoring should be used as medically necessary.Patient, ventilator, and circuit must be monitored on a regular basis per established standards of care." the use of this mask is contraindicated in patients who are unable to remove the mask by themselves.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: AF531 EE LEAK1
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: mr. ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243349303
• MDR Report Key: 11485065
• MDR Text Key: 239786623
• Report Number: 2518422-2021-00677
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 30606959004604
• UDI-Public: 30606959004604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1072629
• Device Catalogue Number: 1072629
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR