Infant Flow™ 7772000LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10190752152687), received between Aug 25, 2023 and Sep 25, 2024 — classified as 1 injury, 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024

  SITUATION/PRIMARY CONCERN: DEFECT - VYAIRE INFANT FLOW GENERATOR NCPAP. BACKGROUND: RT WAS CALLED TO PT BESIDE BY RN TO LOOK AT EQUIPMENT. PT IS RECEIVING NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) THROUGH THE VYAIRE SIPAP MACHINE. RN NOTICED A HOLE IN THE EXPIRATORY LIMB OF THE INFANT FLOW TUBING WHICH WAS LEAKING WATER ONTO PT ISOLETTE BEDDING. RT GRABBED NEW INFANT FLOW GENERATOR KIT FROM CLEAN SUPPLY. WHEN EXCHANGING THE FLOW GENERATOR, RT NOTICED TWO HOLES ON THE NEW FLOW GENERATOR EXPIRATORY LIMB AS WELL. (LOT: 0004262729) RT GRABBED SECOND FLOW GENERATOR KIT WITH DIFFERENT LOT NUMBER, AND IT HAD A HOLE IN IT AS WELL. (LOT: 0004240543). RT CONFIRMED THAT THIS IS A MANUFACTURING ERROR AND HOLES SHOULD NOT BE IN EXPIRATORY LIMB. THIS ERROR DOES NOT EFFECT PT VENTILATION OR OXYGENATION. HOWEVER, DEPENDING ON WHERE THE HOLES ARE LOCATED, THE WATER CAN LEAK OUT CAUSING BEDDING TO GET WET AND BABY POTENTIALLY GETTING COLD. RECOMMENDATION: RT WILL PLACE TAPE AROUND EXPIRATORY LIMB HOLE. IF LEAKING CONTINUES TO BE A PROBLEM, RT WILL EXCHANGE VYAIRE SIPAP FOR SERVO-U VENTILATOR WITH FLEXI TRUNK NCPAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300704 ↗
• InjuryAug 25, 2023Break; Break

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 7772000LP PACKAGE ASSEMBLY,GENERATOR WITHOUT PRONGS BROKE IN HALF WHILE USE ON A BABY. FURTHERMORE, THERE WAS NO HARM DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627949 ↗
• MalfunctionAug 25, 2023Break; Break

  PLASTIC INTERFACE CONNECTING TO GENERATOR BROKE IN HALF WHILE USED ON BABY NOT DURING MANIPULATION OF INTERFACE. NOTED AS BABY WAS CRYING IN ISOLETTE. THE GENERATOR WAS CHANGED, NEW GENERATOR INTEGRITY WAS EXAMINED AND DETERMINED TO BE SAFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625153 ↗