Base unit, Servo-air 6882000Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Maquet Servo-air ventilator base unit has 527 adverse event reports, with 4 deaths and 1 injury. Most reports describe output problems, failed self-tests and alarms, including blower motor and power errors, and one reports the ventilator stopping while a patient was on it. One recall is open, begun in July 2022, because the unit does not meet stability requirements and lacks a required permanent warning about the risk of tipping.
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
- 510
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 510 adverse event reports that list this exact device (DI 07325710003114), received between May 25, 2021 and Sep 25, 2026 — classified as 2 deaths, 508 malfunctions.
The most frequently reported specific device problem is “Output Problem” (343 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K192604); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Jul 21, 2022Open, Classified
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk
Z-1568-2022 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Output Problem343
- Failure of Device to Self-Test102
- Infusion or Flow Problem34
- Power Problem19
- Contamination16
- Gas Output Problem12
- Increase in Pressure8
- Failure to Power Up7
Patient problems
- No Clinical Signs, Symptoms or Conditions507
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 510 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Output Problem
It was reported that the ventilator generated a technical error code indicating Turbine module failure. There was no patient involvement. Manufacturer's Ref. #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895561 ↗MalfunctionSep 25, 2026Output Problem
It was reported that ventilator generated technical error indicating Turbine module communication error. There was no patient harm. Manufacturer's Ref. #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895353 ↗MalfunctionJul 1, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676813 ↗MalfunctionJun 28, 2026Infusion or Flow Problem
THE VENTILATOR GENERATED ALARMS INDICATING INSUFFICIENT VENTILATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25647307 ↗MalfunctionJun 25, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM INDICATING LOW O2 CONCENTRATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618449 ↗MalfunctionJun 23, 2026Output Problem
DURING THE INSPECTION OF THE VENTILATOR IT WAS DISCOVERED THAT PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD WAS DEFECTIVE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25592737 ↗MalfunctionJun 22, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING AN ERROR IN THE INTERNAL MEMORY. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25575199 ↗MalfunctionJun 18, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW 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 25545671 ↗MalfunctionJun 9, 2026Failure of Device to Self-Test; Output Problem
IT WAS REPORTED THAT THE VENTILATOR FAILED O2 CELL/SENSOR 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 25443369 ↗MalfunctionJun 3, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED THE 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 25372451 ↗MalfunctionJun 3, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED THE 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 25372446 ↗MalfunctionMay 27, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW 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 25305983 ↗MalfunctionMay 26, 2026Infusion or Flow Problem; Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED TECHNICAL ERROR CODES INDICATING BLOWER RESTART ERROR. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277391 ↗MalfunctionMay 25, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED THE PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25268770 ↗MalfunctionMay 21, 2026Output Problem
IT WAS REPORTED THAT DURING STANDBY THE VENTILATOR GENERATED TECHNICAL ERROR CODES INDICATING POWER ERRORS AND TURBINE MODULE COMMUNICATION ERROR. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25239712 ↗MalfunctionMay 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 25161642 ↗MalfunctionMay 13, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED A SUB TEST WITHIN THE INTERNAL TEST SEQUENCE, SPECIFICALLY THE BLOWER INLET TEST, DURING THE PRE USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161262 ↗MalfunctionMay 13, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED A SUB TEST WITHIN THE INTERNAL TEST SEQUENCE, SPECIFICALLY THE BLOWER INLET TEST, DURING THE PRE USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161260 ↗MalfunctionMay 11, 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 25135244 ↗MalfunctionMay 7, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW 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 25117725 ↗MalfunctionMay 6, 2026Output Problem
IT WAS REPORTED THAT VENTILATOR GENERATED MULTIPLE TECHNICAL ERRORS INDICATING POWER ERRORS AND TURBINE MODULE COMMUNICATION ERROR. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25091306 ↗MalfunctionApr 29, 2026Improper Flow or Infusion
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM INDICATING LOW POSITIVE END EXPIRATORY PRESSURE (PEEP). THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024565 ↗MalfunctionApr 28, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING AN ERROR IN THE INTERNAL MEMORY. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25012735 ↗MalfunctionApr 24, 2026Leak/Splash; Failure of Device to Self-Test
IT WAS REPORTED THAT VENTILATOR HAD A LEAKAGE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24980557 ↗MalfunctionApr 23, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR WAS AUTO-TRIGGERING. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966567 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192604. One submission often covers many models, so check the product and lot details in each record.
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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