PERFORMAX PERFORMAX PEDIATRIC SE, MPU, W/4 PT HEADGEAR, XXSMALLRecalls & reported problems
Respironics, Inc. · PERFORMAX PEDIATRIC MASK WITH STANDARD ELBOW, MULTI PATIENT USE, WITH FOUR POINT HEADGEAR, EXTRA EXTRA SMALL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959008069), received between Oct 2, 2020 and Oct 2, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
Patient problems
- Cardiac Arrest1
- Loss of consciousness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
THE MANUFACTURER RECEIVED INFORMATION THAT A BABY REQUIRED "REANIMATION" WHEN THE ELBOW OF A PERFORMAX PEDIATRIC MASK BECAME DISCONNECTED FROM THE FACEPLATE HUB WHILE USING NON-INVASIVE VENTILATION. THERE WAS NO CLEAR INFORMATION REGARDING THE STATUS OF THE BABY, OR THE INTERVENTION REQUIRED, AND NO PATIENT INFORMATION WAS PROVIDED. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: Cardiac Arrest; Loss of consciousness
MAUDE report 10622193 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 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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