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

Model Number	1094050
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Serial number of the mask was not provided.
Event or Problem Description
The manufacturer received information that a patient was injured through the use of a wisp nasal mask with magnets when it interfered with an implanted shunt and caused hydrocephalus.The patient was sold a wisp nasal mask on (b)(6) 2022, and once he started using the mask, his ventriculoperitoneal shunt (vps) started resetting to a lower value, causing hydrocephalus.The patient stated they discovered that the mask was impacting them on (b)(6) 2023, when the doctor replaced the strata ii valve of vps due to it having to be reset multiple times and the shunt was still malfunctioning.Despite having open brain surgery to replace the valve, the shunt continued malfunctioning.The patient was advised by his doctor to get a magnet detector, and he found a magnet within the mask.It was reported that the mask did not have the fda warning regarding the magnetic clips that was issued in (b)(6) of 2022 nor was the patient notified that the magnetic clips could impact shunts.The mask has not yet been returned for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously received information that a patient was injured through the use of a wisp nasal mask with magnets when it interfered with an implanted shunt and caused hydrocephalus.The patient was sold a wisp nasal mask on december 28, 2022, and once he started using the mask, his ventriculoperitoneal shunt (vps) started resetting to a lower value, causing hydrocephalus.The patient stated they discovered that the mask was impacting them on august 30, 2023, when the doctor replaced the strata ii valve of vps due to it having to be reset multiple times and the shunt was still malfunctioning.Despite having open brain surgery to replace the valve, the shunt continued malfunctioning.The patient was advised by his doctor to get a magnet detector, and he found a magnet within the mask.It was reported that the mask did not have the fda warning regarding the magnetic clips that was issued in september of 2022 nor was the patient notified that the magnetic clips could impact shunts.The mask has not yet been returned to the manufacturer for evaluation.Three attempts to have the mask returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.The manufacturer has updated section h in this report.

• Brand Name: WISP MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 21961185
• Report Number: 2518422-2025-105164
• Device Sequence Number: 7227975
• Product Code: BZD
• UDI-Device Identifier: 00606959006836
• UDI-Public: (01)00606959006836
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K121631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 1094050
• Device Catalogue Number: 1094050
• Device Lot Number: 0302284291
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1783-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown