Wisp Pediatric Wisp Pediatric Fitpack with Headgear, EE, INTLRecalls & reported problems
Respironics, Inc. · Wisp Pediatric Mask Fitpack with Headgear, with Entrainment Elbow, International · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959026735), received between Jan 23, 2018 and Jan 23, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Issue” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Issue1
- Fitting Problem1
Patient problems
- Injury1
- Swelling1
- Tissue Breakdown1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2018Fitting Problem; Device Issue; Adverse Event Without Identified Device or Use Problem; Fitting Problem; Device Issue
THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION OF SERIOUS INJURY RESULTING IN SURGICAL INTERVENTION ON A PEDIATRIC PATIENT WHILE USING THE WISP PEDIATRIC NASAL MASK DURING NON-INVASIVE VENTILATION. THE PATIENT IS REPORTED TO HAVE DEVELOPED SWELLING AND INFECTION FROM CONTACT WITH THE MASK AND HEADGEAR. NO OTHER INFORMATION HAS BEEN PROVIDED. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: Injury; Swelling; Tissue Breakdown; Unspecified Infection
MAUDE report 7213352 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
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- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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