MAUDE Adverse Event Report: RESPIRONICS, INC. FITPACK, DREAMWEAR FULL, MED. FRAME, GBL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1133400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of an allegation from a user who reportedly went into arrhythmia for about two hours after wearing the dreamwear full face mask with magnetic connections.User reported he did not get any medical intervention and he felt fine after a few hours.User reports he now uses an amara view mask without issues.User also states he does not want to send in his old mask.No product was returned for investigation.The dreamwear instructions for use includes the following warnings: the headgear clips contain magnets.Contact your healthcare professional before you use this mask.Some medical devices may be affected by magnetic fields.The magnetic clips in this mask should be kept at least 2 in.(50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators and cochlear implants.Do not use in or near magnetic resonance imaging (mri) equipment.This report will be filed as an initial-final report.We will continue to monitor these complaints regarding magnets.If any additional information is received, a follow up report will be filed.

• Brand Name: FITPACK, DREAMWEAR FULL, MED. FRAME, GBL
• 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: 13670716
• Report Number: 2518422-2022-07490
• Device Sequence Number: 20212840
• Product Code: BZD
• UDI-Device Identifier: 00606959045897
• UDI-Public: 00606959045897
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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 Model Number: 1133400
• Device Catalogue Number: 1133400
• Device Lot Number: 181122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2018
• 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: Other
• Patient Sex: Male