Ventlab HS4000Recalls & reported problems
Ventlab, LLC · HYPER ELBOW W/MANOMETER · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483084823), received between Apr 20, 2023 and Jan 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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.
Reports received per month
Most reported problems
Device problems
- Component Missing1
- Incomplete or Missing Packaging1
- Material Integrity Problem1
- Output Problem1
Patient problems
- Bradycardia1
- Low Oxygen Saturation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2025Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem
RECEIVED MDR MEDWATCH REPORT FROM FDA REPORTING THAT AN ADULT UNIT CODE BLUE ON INTUBATED PATIENT. ATTEMPTING TO BAG/VENTILATE PATIENT. PRESSURE RELEASE VALVE WAS NOT FUNCTIONING PROPERLY. THE BAG HYPERINFLATED REGARDLESS OF POSITIONING OF VALVE THROUGH ENTIRE SPECTRUM OF ITS DIALING. COULD NOT PROPERLY DELIVER VENTILATION TO PATIENT UNTIL SECOND BAG WAS BROUGHT IN. IT WAS DETERMINED THIS IS A REPORTABLE EVENT FOR 1 INCIDENT.
Patient problems: Low Oxygen Saturation
MAUDE report 21172660 ↗InjuryApr 20, 2023Component Missing; Incomplete or Missing Packaging; Component Missing; Incomplete or Missing Packaging
BLUE CAP COVERING PORT WAS MISSING. ATTEMPTED TO USE VENTILATING BAG DEVICE, INITIALLY VENTILATING WELL, THEN NOTED TO NOT HAVE CHEST RISE AND DIFFICULTY VENTILATING OR ACHIEVING ADEQUATE SATURATIONS. THIS IMPROVED UPON SWITCHING THE BAG BUT PATIENT EXPERIENCED BRADYCARDIA REQUIRING INTERVENTION. UPON CLOSER LOOK AT THE DEVICE RESPIRATORY THERAPIST NOTED THAT BLUE CAP COVERING A PORT WAS MISSING.
Patient problems: Bradycardia
MAUDE report 16776824 ↗
Other Resuscitator,Manual,Non Self-Inflating devices
- Ventlab HS4011Ventlab, LLC · Resuscitator,Manual,Non Self-Inflating5 reports
- Ventlab HS4051Ventlab, LLC · Resuscitator,Manual,Non Self-Inflating1 report
- Hyperinflation System 10-55833Mercury Enterprises, Inc. · Resuscitator,Manual,Non Self-Inflating1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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