MAUDE Adverse Event Report: RESPIRONICS INC PERFORMATRAK MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1049037
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging that while on a bilevel positive airway pressure (bipap) device, a patient became confused and removed the performax mask.The patient subsequently required intubation due to oxygen desaturation.The manufacturer has made numerous attempts to contact the reporting facility to gather additional information and to request return of the mask for investigation.No further information has been provided, and no product has been returned.The performatrak full 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.The mask is to be used on patients (>66lbs/30kg) for whom cpap or bi-level therapy has been prescribed.Labeling warns the user "this mask is not suitable for providing life support ventilation", and that "this mask should not be used on patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask." as no further information was provided, and no product returned, the manufacturer is unable to determine the root cause of the reported event.The manufacturer concludes no further action is necessary.

• Brand Name: PERFORMATRAK MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11517382
• Report Number: 2518422-2021-00679
• Device Sequence Number: 14436080
• Product Code: BZD
• UDI-Device Identifier: 00606959000759
• UDI-Public: 00606959000759
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K091271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: No Information
• Device Model Number: 1049037
• Device Catalogue Number: 1049037
• Device Lot Number: 46782941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/18/2021
• 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