MAUDE Adverse Event Report: RESPIRONICS, INC. M AF811 MASK; FULL FACE MASK

Model Number 1063052

Device Problem Complete Blockage (1094)

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

Event Date 12/09/2023

Event Type  malfunction  

Manufacturer Narrative

Device information in complaint details: 1063052 c-pap nasal mask (medium) ¿ ref (b)(4) and lot: 191114 same patient, additional device (mask) captured in complaint ra (b)(4) h3 other text : device not returned to manufacturer.

Event Description

The manufacturer was contacted in reference to a af811 oro-nasal mask.The patient alleges while in use, the safety valve closes on a spontaneous breath on the nasal mask.At the time this issue occurred, use of the device was stopped and restarted.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information n reference to a af811 oro-nasal mask.The patient alleges while in use, the safety valve closes on a spontaneous breath on the nasal mask.At the time this issue occurred, use of the device was stopped and restarted.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Updated: section b: adverse event/product problem: changed to "product problem".Section h: type of reported complaint: changed to "product problem".Section h: health impact grid: changed to "no health consequences or impact".

• Brand Name: M AF811 MASK
• Type of Device: FULL FACE MASK
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18472273
• MDR Text Key: 332372175
• Report Number: 2518422-2024-01291
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 30606959034359
• UDI-Public: 30606959034359
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1063052
• Device Catalogue Number: 1063052
• Device Lot Number: 191114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention