Vital Signs™ 6821Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752147423), received between Dec 16, 2021 and Dec 16, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Defective Component” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2021Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS® INFANT FACE MASK SIZE 1 AND 2 RING WAS DEFLATED WHEN REMOVED FROM THE BAG. SAMPLE WAS PULLED TO USE IN EMERGENT SITUATIONS, DEFLATION CAUSES DELAY IN PATIENT CARE. AS AN INTERVENTION, THE CLINICIANS HAD TO GET SYRINGE AND FILL MASK WITH AIR BEFORE BEING ABLE TO RESCUE VENTILATE CHILD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13023250 ↗
• InjuryDec 16, 2021Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS® INFANT FACE MASK SIZE 1 AND 2 RING WAS DEFLATED WHEN REMOVED FROM THE BAG. SAMPLE WAS PULLED TO USE IN EMERGENT SITUATIONS, DEFLATION CAUSES DELAY IN PATIENT CARE. AS AN INTERVENTION, THE CLINICIANS HAD TO GET SYRINGE AND FILL MASK WITH AIR BEFORE BEING ABLE TO RESCUE VENTILATE CHILD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13023213 ↗