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

Model Number 1094088

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Nodule (4551)

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text: not returned to manufacturer.

Event Description

The manufacturer became aware of an allegation that a wisp mask with magnets caused an end user to develop a lump on her face.The user alleges there was a hole under the magnet, and she woke up in the morning and had a lump on her face which eventually started to ooze.The user alleges she would change the mask every 3 months and would clean it daily with soap and water.The user discontinued using her mask on the advice of her doctor and the lesion healed without medical treatment.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.

Manufacturer Narrative

The manufacturer previously reported an allegation that a wisp mask with magnets caused an end user to develop a lump on her face.The user alleged there was a hole under the magnet, and she woke up in the morning and had a lump on her face which eventually started to ooze.The user alleged she would change the mask every 3 months and would clean it daily with soap and water.The user discontinued using her mask on the advice of her doctor and the lesion healed without medical treatment.The manufacturer previously reported this allegation as both a serious injury and product problem.After further review, it was determined this allegation is a product problem only.

• 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 15208 ; 4125423300
• MDR Report Key: 16764204
• MDR Text Key: 313529038
• Report Number: 2518422-2023-09152
• Device Sequence Number: 1
• Product Code: BZD
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1094088
• Device Catalogue Number: 1094088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES90705
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female