• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RESPIRONICS, INC. WISP MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15761076
MDR Text Key306063344
Report Number2518422-2022-92662
Device Sequence Number1
Product Code BZD
UDI-Device Identifier00606959006829
UDI-Public00606959006829
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121631
Number of Events Reported1
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 Number1094051
Device Catalogue Number1094051
Device Lot Number170718
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2017
Initial Date FDA Received11/09/2022
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 Number1
-
-