MAUDE Adverse Event Report: RESPIRONICS, INC. PERFORMAX EE TOTAL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1052532
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/31/2016
Type of Reportable Event	Death
Event or Problem Description
A voluntary medwatch (b)(4) was received by the manufacturer on 11/28/2016, indicating a patient death had occurred in a facility on (b)(6) 2016.The patient had a significant medical history of dementia, diastolic congestive heart failure, and atrial fibrillation, and had been admitted to the intensive care unit (icu) with hypercapnic respiratory failure.The report indicated that the (b)(6) female was placed on a medical-surgical floor after being discharged from icu, and was using a bi-level positive airway pressure (bipap), a performax total face mask, and a bipap disposable patient circuit.The patient was subsequently found in cardiac arrest, with the bipap patient circuit detached from the mask.Resuscitation was unsuccessful.The exact cause of death remains unknown because the family declined an autopsy.The risk manager for the facility confirmed the bipap serial number and catalog number to the manufacturer after the initial report was filed, and stated the device did not annunciate an alarm for patient disconnect because it was not the type of device that had alarms built in.The performax full face mask and bipap patient circuit were discarded by the facility.The bipap (bipap auto, pn 760p, sn (b)(4)) was not indicated as causing or contributing to the adverse event, and was not returned for evaluation.No lot number was provided for the performax mask.The performax ee total 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 only.The small size mask is to be used on patients 7 years or older (>20 kg) for whom cpap or bi-level therapy has been prescribed.The large and extra-large size masks are to be used on patients (>30 kg) for whom cpap or bi-level therapy has been prescribed.Labeling warns the user that this mask is not suitable for providing life support ventilation, and that appropriate patient monitoring should be used as medically necessary.This mask should not be used on patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask.The bipap auto device delivers positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over 30 kg (66 lbs.).It is for use in the hospital/institutional environment.Labeling cautions the user that this device is not intended for life support.It does incorporate a "mask alert" function that may be enabled by the user to detect and sound an audible alert if a significant leak is detected.It is unknown if this function was enabled at the time of the reported event.Since the performax total face mask and bipap patient circuit were discarded by the facility, and the bipap has not been returned for investigation, the manufacturer is unable to confirm that the reported disconnect of the mask and circuit may have caused or contributed to the event.There is no allegation the bipap caused or contributed to the event.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: PERFORMAX EE TOTAL FACE MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 6198809
• Report Number: 2518422-2016-04730
• Device Sequence Number: 52618
• Product Code: BZD
• UDI-Device Identifier: 30606959004086
• UDI-Public: 30606959004086
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K091271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/28/2016

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: Health Professional
• Device Model Number: 1052532
• Device Catalogue Number: 1052532
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/22/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIPAP AUTO, SN (B)(4); BIPAP DISPOSABLE CIRCUIT
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR