Vapotherm MI1300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841737100010), received between May 15, 2020 and May 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2020Break

  TUBING DETACHED FROM THE CANNULA. REPORT FROM STAFF: I WAS FEEDING BABY X AND WHEN MOM ARRIVED THE PLAN WAS THAT I WOULD GIVE INFANT A BURP BREAK AND THEN LET MOM FINISH THE REST OF THE FEEDING. INFANT IS ON VAPOTHERM WITH FIO2 AT 42%. I HAD THE VAPOTHERM CLIPPED TO BABY'S OUTFIT SO THAT IT DIDN'T PULL ON HER FACE. WHEN I STOOD UP TO BURP HER THE VAPOTHERM UNCLIPPED AND THE WEIGHT OF THE TUBING SNAPPED THE VAPOTHERM CANULA AT THE BASE MAKING THIS CANULA USELESS. I VERBALLY CALLED OUT FOR THE NURSE AND SHE RESPONDED. I PLACED INFANT IN HER CRIB AND AT THAT TIME SHE WAS DOING GREAT AT 89%. I RAN TO THE SUPPLY ROOM TO GRAB A NEW TUBING AND RETURNED WITH THIS WITHIN 25 SECONDS. AT THAT TIME INFANT WAS TURNING BLUE AND WAS DESATING INTO 40'S. APPLIED CPAP WITH FIO2 OF 60% AND PUSHED STAFF ASSIST BUTTON. INFANT STARTED TO RECOVER UNTIL SHE HAD A SPIT UP OF WHICH SHE DESAT TO 34% AND RN SUCTIONED NOSE AND MOUTH. DR. (B)(6) AND FULL TEAM ARRIVED. INFANT DOING OK NOW, ALERT, ACTIVE AND RECOVERED INTO 90'S. I FILLED OUT A MIDAS REPORT AS IT WAS THE VAPOTHERM TUBING THAT SNAPPED ABOVE THE CONNECTOR."

  Patient problems: Cyanosis; Hypoxia; Low Oxygen Saturation; Vomiting

  MAUDE report 10062027 ↗