Hyperinflation AMBU 900 000 614Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05707480137527), received between Mar 25, 2025 and May 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED, IT WOULD NOT ALLOW FOR THE MASK TO FIT INTO THE BAG, MAKING THE BAG INOPERATIVE DURING A CRUCIAL RESUSCITATION TIME IN THE DELIVERY ROOM. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22101843 ↗
• MalfunctionMay 10, 2025Misassembled; Misassembled

  IT WAS REPORTED, THE PEDIATRIC PATIENT EXPERIENCED A DELAY IN CARE DUE TO THE MIS-ASSEMBLY OF THE DEVICE (THE BAG WAS ON THE PORT FOR THE MASK AND VICE VERSA). THE MEDICAL TEAM GAVE THE BABY BLOW BY WHILE A DIFFERENT DEVICE WAS SOURCED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999640 ↗
• MalfunctionApr 8, 2025Misassembled; Misassembled

  DURING PATIENT CARE, IN THE DELIVERY ROOM, IT WAS DISCOVERED THE BAG WAS ATTACHED ON THE WRONG SIDE; THE PRESSURE POP-OFF WAS PLACED NEAR THE MASK AND THE PRESSURE GAUGE WAS FACING SIDE-WAYS, THIS CAUSED AN IMPROPER FIT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21798265 ↗
• MalfunctionMar 25, 2025Component Misassembled; Component Misassembled

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2025-00010 FOR THE SECOND REPORT. REFER TO 2028807-2025-00011 FOR THE THIRD REPORT. IT WAS REPORTED, THE CLEAR CONNECTOR PIECE WAS INSTALLED INCORRECTLY INTO THE BALLOON WHICH CAUSED THE NEONATAL MASK NOT TO FIT PROPERLY AND RESULTED IN CONFUSION DURING TREATMENT AND A DELAY IN CARE AS THE HEALTHCARE PROFESSIONAL HAD TO DISASSEMBLE AND REASSEMBLE THE INFLATION SYSTEM IN ORDER TO MAKE IT FUNCTIONAL AND OR FIND ONE THAT WAS CORRECTLY ASSEMBLED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692428 ↗
• MalfunctionMar 25, 2025Component Misassembled; Component Misassembled

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2028807-2025-00009 FOR THE FIRST REPORT. REFER TO 2028807-2025-00010 FOR THE SECOND REPORT. IT WAS REPORTED, THE CLEAR CONNECTOR PIECE WAS INSTALLED INCORRECTLY INTO THE BALLOON WHICH CAUSED THE NEONATAL MASK NOT TO FIT PROPERLY AND RESULTED IN CONFUSION DURING TREATMENT AND A DELAY IN CARE AS THE HEALTHCARE PROFESSIONAL HAD TO DISASSEMBLE AND REASSEMBLE THE INFLATION SYSTEM IN ORDER TO MAKE IT FUNCTIONAL AND OR FIND ONE THAT WAS CORRECTLY ASSEMBLED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692415 ↗
• MalfunctionMar 25, 2025Component Misassembled; Component Misassembled

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2028807-2025-00009 FOR THE FIRST REPORT. REFER TO 2028807-2025-00011 FOR THE THIRD REPORT. IT WAS REPORTED, THE CLEAR CONNECTOR PIECE WAS INSTALLED INCORRECTLY INTO THE BALLOON WHICH CAUSED THE NEONATAL MASK NOT TO FIT PROPERLY AND RESULTED IN CONFUSION DURING TREATMENT AND A DELAY IN CARE AS THE HEALTHCARE PROFESSIONAL HAD TO DISASSEMBLE AND REASSEMBLE THE INFLATION SYSTEM IN ORDER TO MAKE IT FUNCTIONAL AND OR FIND ONE THAT WAS CORRECTLY ASSEMBLED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692411 ↗