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

Model Number 1137437

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Paralysis (1997)

Event Date 08/06/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an end user had a heart attack and stroke while using the dreamwear full face mask with magnets.The user alleges she has used the mask since (b)(6) and had a heart attack on (b)(6) 2022, and a stroke on (b)(6) 2022, which caused her to be paralyzed.The user states she is taking medication to keep her blood pressure down and blood thinners and is doing better.Multiple attempts to contact the user for further information have been unsuccessful.No product will be returned for investigation.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

• Brand Name: DREAMWEAR FULL FACE MASK
• 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 15206 ; 2673970028
• MDR Report Key: 15806131
• MDR Text Key: 303737073
• Report Number: 2518422-2022-94473
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959050617
• UDI-Public: 00606959050617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 1137437
• Device Catalogue Number: 1137437
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR