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

Model Number	1094051
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Arrhythmia (1721); Atrial Fibrillation (1729); Bradycardia (1751); Nausea (1970); Vomiting (2144)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation that an end user experienced nausea, throwing up, severe atrial fibrillation and low heart rate while using the wisp mask with magnets.The end user alleges he was hospitalized in september 2021 for 3 to 4 days to stabilize his heart and have his pacemaker checked.Multiple attempts to obtain more information were 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.
Additional Manufacturer Narrative
Not returned to manufacturer.
Additional Manufacturer Narrative
Corrected data includes update to the type of reported complaint changes to product problem.
Additional Manufacturer Narrative
On previously submitted report, section "adverse event/product problem" in box b was incorrect.In this report, section "adverse event/product problem" in box b has been updated/corrected.

• Brand Name: WISP MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16086464
• Report Number: 2518422-2023-00246
• Device Sequence Number: 20509611
• Product Code: BZD
• UDI-Device Identifier: 00606959006829
• UDI-Public: 00606959006829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup

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: 1094051
• Device Catalogue Number: 1094051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 08/04/2023; 10/18/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 08/04/2023; 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES90705
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male