N/A 7600-0Recalls & reported problems
Salter Labs · Bubble Humidifier with 6 PSI safety valve. · Class 2
- 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 00607411700040), received between Aug 3, 2020 and Aug 3, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
- No Flow1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2020Leak/Splash; No Flow; Therapeutic or Diagnostic Output Failure
BLOOD O2 BELOW 50%. OXYGEN SUDDENLY STOPPED FLOWING FROM OUTPUT OF SALTER LABS BUBBLE HUMIDIFIER 7600-0 WITH NO INDICATION OF FAILURE. 3 OUT OF 3 FAILED AFTER JUST A FEW HOURS USE. TEST SHOWED LEAK AT PRESSURE RELIEF VALVE. TESTED RELIEF VALVE PER INSTRUCTIONS AND IT ACTIVATED AND RESET, BUT STILL LEAKED. FIRST FAILURE WAS NOTICED WHEN PATIENTS LIPS TURNED BLUE. REPLACED WITH 2ND UNIT AND FLOW RESUMED UNTIL IT SUDDENLY STOPPED WITH NO INDICATION. LIKEWISE WITH 3RD UNIT. LOT NUMBER (10) 062419. THIS IS A SERIOUS PROBLEM THAT COULD CAUSE DEATH. SEE PRODUCT RECALL FROM 2012 FOR SAME PROBLEM. RECALL NUMBER: Z-0803-2012 RECALL EVENT ID 60270. FDA SAFETY REPORT ID #: (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10361791 ↗
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- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.