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

Model Number 1118066

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 10/19/2022

Event Type  Death  

Event 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
• 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: 15772995
• MDR Text Key: 303441251
• Report Number: 2518422-2022-92652
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959051928
• UDI-Public: 00606959051928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1118066
• Device Catalogue Number: 1118066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2022
• 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): Death