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

Model Number	1072629
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11485065
• Report Number: 2518422-2021-00677
• Device Sequence Number: 3804835
• Product Code: MNS
• UDI-Device Identifier: 30606959004604
• UDI-Public: 30606959004604
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1072629
• Device Catalogue Number: 1072629
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR