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

Model Number	1118066
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	10/19/2022
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging an end user's pacemaker failed and the patient expired while using the wisp mask with magnetic connections.The actual date of death is unknown.The user allegedly had the pacemaker for 2 months when he started having difficulty breathing, hypoxemia, and atrial fibrillation.The user's spouse stated he was awake and sitting on the couch when the pacemaker failed and was not wearing the mask at the time.The spouse stated she believes the magnets were less than 2 inches from the pacemaker when the mask was worn because her husband would sleep with his head and chin down on his shoulder and she thinks the magnets were down on his shoulder.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: WISP MASK
• Common Device Name: 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: 15772995
• Report Number: 2518422-2022-92652
• Device Sequence Number: 3062626
• Product Code: BZD
• UDI-Device Identifier: 00606959051928
• UDI-Public: 00606959051928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1118066
• Device Catalogue Number: 1118066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown