MAUDE Adverse Event Report: RESPIRONICS, INC. PERFORMATRAK FULL FACE MASK, EE; VENTILATOR, NON CONTINUOUS RESPIRATOR

Model Number CN1012573

Device Problem Material Separation (1562)

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

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the mask was discarded.

Event Description

The manufacturer became aware of an allegation that a user wearing a performatrak mask became disconnected during non-invasive ventilation therapy.The reporter alleged that the mask connector came off when removing the mask due to wiping the water inside of it.When trying to reconnect them together, the connector became loose, and the circuit could not be reconnected for treatment.The event caused delay in treatment.The mask was replaced for the user.The hospital gave feedback in an email later stating there were not any health consequences and admitted improper use caused the event, but no additional details were provided.The mask is not available for investigation.The manufacturer believes they will be unable to gather additional information.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: PERFORMATRAK FULL FACE MASK, EE
• Type of Device: VENTILATOR, NON CONTINUOUS RESPIRATOR
• 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: 17798311
• MDR Text Key: 324030257
• Report Number: 2518422-2023-24119
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002465
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CN1012573
• Device Catalogue Number: CN1012573
• Device Lot Number: 210625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1