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

Model Number 1094051

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2017

Event Type  malfunction  

Event Description

The manufacturer received information that an end user allegedly received the wisp mask with magnetic connections and was concerned because she has a pacemaker/defibrillator and was worried the magnetic clips would affect her heart.The user was instructed to keep the mask 6-8 inches from her heart and to also speak with her doctor.The user is concerned when turning in her sleep she might cause herself harm.There was no report of medical intervention.There was no report of patient harm or injury.No product will be returned for investigation.The wisp 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.Keep unassembled magnetic headgear clips out of reach of children.In case of accidental swallowing, seek medical assistance immediately.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: 15761076
• MDR Text Key: 306063344
• Report Number: 2518422-2022-92662
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959006829
• UDI-Public: 00606959006829
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1094051
• Device Catalogue Number: 1094051
• Device Lot Number: 170718
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 11/09/2022
• 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