MONSOON+ 7700.USRecalls & reported problems

Acutronic Medical Systems AG · High frequency ventilator · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640140861616), received between Jul 18, 2019 and Sep 17, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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

Device problems

Electrical /Electronic Property Problem2
Mechanical Problem2
Display or Visual Feedback Problem1

Patient problems

No Information3
No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 17, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED THAT THE DEVICE EXPERIENCED BUZZER ISSUES. AT THIS TIME, THERE WAS NO INFORMATION PROVIDED REGARDING PATIENT INVOLVEMENT IN THIS EVENT.
Patient problems: No Information
MAUDE report 9078237 ↗
MalfunctionSep 17, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE DEVICE WAS EXPERIENCING "FIO2 NOT STABLE". AT THIS TIME, THERE WAS NO INFORMATION PROVIDED REGARDING PATIENT INVOLVEMENT IN THIS EVENT.
Patient problems: No Information
MAUDE report 9077989 ↗
MalfunctionAug 16, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE DEVICE EXPERIENCED DISPLAY ISSUES. AT THIS TIME, THERE WAS NO INFORMATION PROVIDED REGARDING PATIENT INVOLVEMENT IN THIS EVENT.
Patient problems: No Information
MAUDE report 8903785 ↗
InjuryAug 16, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE DEVICE STOPPED VENTILATING DURING CLINICAL USE. ADDITIONALLY, AN ERROR MESSAGE "ELECTRONIC ERROR" OCCURRED DURING THE INITIATION OF THE PATIENT TO MICROLARYNGOSCOPY. ALL BUTTONS WERE INOPERATIVE AND DISPLAY IS NOT FUNCTIONING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8903212 ↗
InjuryJul 18, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED THAT THE MONSOON VENTILATOR ALARMED WITH THE FOLLOWING ISSUES: PEAK INSPIRATORY PRESSURE (PIP) MEASURING ELECTRONIC ERROR AND DRIVING (DP) MEASURING ELECTRONIC ERRORS. THE ISSUE OCCURRED DURING PATIENT USE IN ADULT DOUBLE JET VENTILATION MODE. THE CUSTOMER REPORTED THE ERROR OCCURRED TWICE DURING A TWELVE HOUR SHIFT AND WAS STILL IN USE. AT THIS TIME, THERE IS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8805622 ↗

Device details

UDI-DI	`07640140861616`
Brand	MONSOON+
Model	7700.US
Company	Acutronic Medical Systems AG
Product code	CBK · VENTILATOR, CONTINUOUS, FACILITY USE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jan 19, 2023

Device type (GMDN): Stationary electric high-frequency ventilator

A mains electricity (AC-powered) automatic cycling machine intended to assist or control alveolar ventilation using a frequency that is considerably higher than the physiological breathing rate and a tidal volume less than or equal to the anatomic dead space. The device will typically function independently or may be used in conjunction with an intensive care ventilator to superimpose its high frequency percussive ventilation on top of a normal ventilation frequency. It is typically used in critical care situations on patients with respiratory disease requiring ventilatory assistance, typically through an artificial airway [e.g., endotracheal (ET) tube or tracheostomy].

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All VENTILATOR, CONTINUOUS, FACILITY USE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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