MAUDE Adverse Event Report: RESPIRONICS INC DREAMWEAR UNDER THE NOSE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1116685
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Insufficient Information (4580)
Date of Event	11/28/2020
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a ventilator dependent patient was using a dreamwear continuous positive airway pressure (cpap) device mask with a ventilator.The connector on the dreamwear mask became broken and was unable to be reattached for use.Although a different mask was placed on the patient after the dreamwear mask became broken, the patient subsequently suffered a heart condition and died.The date of the patient death is currently unknown.The device has yet to be returned to manufacturer for evaluation.At this time, we are unable to confirm the allegation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging a breakage of a dreamwear utn continuous positive airway pressure (cpap) mask occurred and a ventilator dependent patient subsequently died.The manufacturer received the dreamwear utn mask for evaluation.During the evaluation of the mask it was noted that the cushion of the mask, the frame of the mask and the mask elbow were from different lot numbers.Excessive wear was also noted to the mask so that the mask cushion was unable to take form on the manufacturer's mannequin.The manufacturer believes that the excessive wear of the mask and the usage of multiple parts from different lot numbers likely resulted in the inability of the mask to stay connected and in place for appropriate usage by the patient.The dreamwear utn nasal mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single patient use in the home or multi-patient 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.Product labeling warns users "this mask is not suitable for providing life support ventilation." the manual instructs users prior to use to "inspect the entire mask.Discard and replace any damaged or worn parts.The useful life of the mask depends on the use conditions and maintenance (cleaning, institutional disinfection, and component replacement) of the device.Inspect the mask parts regularly for damage or wear.Replace components as deemed necessary.".

• Brand Name: DREAMWEAR UNDER THE NOSE MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 10985172
• Report Number: 2518422-2020-02991
• Device Sequence Number: 779406
• Product Code: BZD
• UDI-Device Identifier: 00606959030787
• UDI-Public: 00606959030787
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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: No Information
• Device Model Number: 1116685
• Device Catalogue Number: 1116685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 12/30/2020
• 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