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

Model Number	1012574
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Death (1802); Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem Description
The manufacturer was made aware of an allegation of a patient death as a result of the patient circuit becoming detached from the mask.There was no patient information provided, and no other details of the alleged event.The date of the reported event is unknown.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.
Additional Manufacturer Narrative
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.Note on mdr 2518422-2020-03042-1, were blank.This report is being filed as a correction to that report, with the additional information reported on this supplemental report mdr 2518422-2020-03043-1.

• 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: 11012452
• Report Number: 2518422-2020-03042
• Device Sequence Number: 4495748
• Product Code: BZD
• UDI-Device Identifier: 00606959007581
• UDI-Public: 00606959007581
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K002465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012574
• Device Catalogue Number: 1012574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 02/11/2021; 02/11/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/15/2021; 02/25/2021
• 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: Death