Airlife™ 6600-0628-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752181236), received between Jul 29, 2022 and Aug 17, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Heating” (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

Recent adverse event reports

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

• InjuryAug 17, 2022Insufficient Heating; Insufficient Heating

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 6600-0628-700 LULLABY REUSABLE SKIN TEMPERATURE PROBE WON'T WARM THE BABIES (TEMPERATURE PROBE ERROR/FAILURE). THEY SWITCHED OUT THE DEVICE BUT STAY THE SAME. THERE WAS NO PATIENT IMPACT/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246515 ↗
• MalfunctionJul 29, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LULLABY REUSABLE SKIN TEMPERATURE PROBE WAS MALFUNCTIONING WHILE CONNECTED TO A PATIENT. THE CUSTOMER STATED THAT THE PROBE WAS REPLACED AND THE PATIENT WAS TRANSFERRED TO ANOTHER STATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15136510 ↗