MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AF811 SU FULL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1120251

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

The manufacturer became aware of an allegation that the safety valve on a af811 su full face mask closes when the patient takes a spontaneous breath which is a potential safety risk due to airway restriction while the patient is breathing.The manufacturer is unaware of what exhalation safety valve was used with this mask.There was no report of patient harm or injury.Attempts to obtain more information have been unsuccessful.The product has not been returned to the manufacturer.The manufacturer's investigation is ongoing.A final report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation that the safety valve on a af811 su full face mask closed when the patient took a spontaneous breath which was a potential safety risk due to airway restriction while the patient was breathing.The manufacturer is unaware of what exhalation safety valve was used with this mask.There was no report of patient harm or injury.Repeated attempts to obtain more information and to have the masks returned for investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: AF811 SU FULL FACE MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16015320
• MDR Text Key: 305829636
• Report Number: 2518422-2022-102559
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K073600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1120251
• Device Catalogue Number: 1120251
• Device Lot Number: 200903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1