Base Unit SERVO-n 6688600Recalls & reported problems
Maquet Critical Care AB · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Maquet Servo-n ventilator has 107 reports, including 1 death and 8 injuries. Many reports describe the ventilator's output or flow failing, failed self-tests, and leaks, and some describe water found in the gas module and oxygen settings that were set too high. Reports fell from 34 in the prior 12 months to 16 in the latest 12 months. There is 1 recall, still open, started in May 2025 over possibly inaccurate measurement of patient circuit compliance, linked to an incorrect pre-use leak test and the wrong humidifier.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 104
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 07325710001042), received between Feb 15, 2021 and Jun 2, 2026 — classified as 1 death, 8 injuries, 95 malfunctions.
The most frequently reported specific device problem is “Output Problem” (49 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (K151814, K180098, K201874); they may or may not involve this specific model.
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.
Reports received per month
Recalls naming this device
- May 30, 2025Open, Classified
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Z-2013-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Output Problem49
- Infusion or Flow Problem16
- Failure of Device to Self-Test13
- Increase in Pressure6
- Improper Flow or Infusion4
- Leak/Splash4
- Pressure Problem3
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions94
- Bradycardia4
- Low Oxygen Saturation4
- Pneumothorax3
- Respiratory Insufficiency2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Contamination /Decontamination Problem; Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW TRANSDUCER TEST DURING PRE-USE CHECK. MOREOVER, WATER HAS BEEN FOUND IN AIR GAS MODULE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360375 ↗MalfunctionApr 16, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST AND PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24893389 ↗MalfunctionApr 15, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM INDICATING FLUCTUATION BETWEEN LOW AND HIGH O2 CONCENTRATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24882384 ↗MalfunctionApr 3, 2026Infusion or Flow Problem
REVIEW OF THE DEVICE'S LOGS REVEALED THAT NEONATE WAS EXPOSED TO TOO HIGH O2 CONCENTRATION FOR AN EXTENDED PERIOD OF TIME. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775024 ↗MalfunctionMar 16, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE SET OXYGEN CONCENTRATION VALUE WAS UNINTENTIONALLY INCREASED TO 87%. THE PATIENT RECEIVED TOO HIGH AMOUNT OF ADDITIONAL OXYGEN FOR APPROXIMATELY ONE HOUR. WHEN DISCOVERED, THE OXYGEN CONCENTRATION WAS LOWERED TO THE INITIAL SET VALUE OF 25%. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603080 ↗MalfunctionMar 9, 2026Improper Flow or Infusion
MANUFACTURER¿S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543147 ↗MalfunctionFeb 18, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST WITH A MESSAGE 'PRESSURE TRANSDUCER DIFFERENCE > 5 CMH2O' DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24374744 ↗MalfunctionJan 19, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108311 ↗MalfunctionJan 13, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050657 ↗MalfunctionDec 23, 2025Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED CLINICAL ALARMS INDICATING INSUFFICIENT VENTILATION DURING TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882796 ↗MalfunctionDec 8, 2025Incorrect Measurement; Incorrect Measurement
MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741650 ↗MalfunctionNov 20, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST WITH A MESSAGE "SYSTEM VOLUME TOO SMALL" DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602209 ↗MalfunctionNov 6, 2025Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT THERE WAS ISSUE WITH INACCURATE RESPIRATORY RATE DURING VENTILATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484944 ↗MalfunctionOct 15, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM OF AIRWAY PRESSURE HIGH. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288883 ↗MalfunctionSep 17, 2025Tidal Volume Fluctuations; Tidal Volume Fluctuations
IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR LOW MINUTE VOLUME. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073895 ↗MalfunctionSep 8, 2025Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE VENTILATION STOPPED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22989923 ↗MalfunctionSep 2, 2025Output Problem; Output Problem
MANUFACTURER'S REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932250 ↗MalfunctionAug 29, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARM INDICATING LEAK. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22920464 ↗MalfunctionAug 20, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE VENTILATOR STOPPED PROVIDING FLOW WHILE IN USE ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: 1338379.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22848052 ↗MalfunctionAug 18, 2025Output Problem; Output Problem
MANUFACTURER'S REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22824952 ↗MalfunctionAug 18, 2025Output Problem; Output Problem
MANUFACTURER'S REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22824950 ↗MalfunctionAug 11, 2025Output Problem; Output Problem
IT WAS REPORTED THAT WHILE THE VENTILATOR WAS VENTILATING A PATIENT IN THE NIV-NAVA (NON-INVASIVE VENTILATION NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, A LEAKAGE WAS DETECTED. THE VENTILATOR CONSTANTLY WENT IN TO BACKUP VENTILATION. THERE WAS NO PATIENT HARM. MANUFACTURER' REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22768971 ↗MalfunctionAug 6, 2025Output Problem; Output Problem
IT WAS REPORTED THAT WHILE THE VENTILATOR WAS VENTILATING A PATIENT IN THE NIV NAVA (NON-INVASIVE VENTILATION NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, A LEAKAGE WAS DETECTED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725456 ↗MalfunctionAug 6, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARM INDICATING O2 CONCENTRATION BEING TOO LOW. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22724876 ↗MalfunctionJul 29, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641225 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K151814, K180098, K201874. One submission often covers many models, so check the product and lot details in each record.
- Z-2963-2026 · Jun 30, 2026 · Open, ClassifiedGETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
- Z-2014-2025 · May 30, 2025 · Open, ClassifiedServo-n Ventilator System. Model Number: 6694800.
- Z-2015-2025 · May 30, 2025 · Open, ClassifiedServo-u MR Ventilator System. Model Number: 6888800.
- Z-1560-2022 · Jul 20, 2022 · Open, ClassifiedMaquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.