Servo-s Base Unit 6640440Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Maquet Servo-s ventilator has 799 adverse event reports, including 3 deaths and 18 injuries. Many describe output problems, failed self-tests and gas leaks, and most mention no effect on the patient. No recalls name this device. Reports fell from 263 in the previous 12 months to 168 in the most recent 12 months.
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
- 795
- Deaths reported
- 3
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 795 adverse event reports that list this exact device (DI 07325710001127), received between Nov 20, 2020 and Sep 30, 2026 — classified as 3 deaths, 20 injuries, 772 malfunctions.
The most frequently reported specific device problem is “Output Problem” (392 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.
Reports received per month
Most reported problems
Device problems
- Output Problem392
- Failure of Device to Self-Test305
- Mechanical Problem56
- Infusion or Flow Problem52
- Contamination44
- Gas/Air Leak35
- Improper Flow or Infusion17
- Leak/Splash13
Patient problems
- No Clinical Signs, Symptoms or Conditions771
- Low Oxygen Saturation21
- Bradycardia2
- High Blood Pressure/ Hypertension2
- Insufficient Information2
- Irregular Pulse2
- Loss of consciousness1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 795 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Infusion or Flow Problem
It was reported that the ventilator generated an alarm indicating high O2 concentration. There was no patient harm. Manufacturer's Ref. #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946619 ↗InjurySep 25, 2026Infusion or Flow Problem
It was reported that during patient ventilation, ventilator generated an O2 Sensor failure alarm while connecting to an O2 concentrator. Patient's saturation decreased to unknown level. The ventilator was replaced.Final patient outcome was no harm.Manufacturer's Ref.#: (b)(4).
Patient problems: Low Oxygen Saturation
MAUDE report 50898137 ↗MalfunctionSep 25, 2026Failure of Device to Self-Test
It was reported that the ventilator failed Internal leakage 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 50895928 ↗InjurySep 25, 2026Infusion or Flow Problem
It was reported that during patient ventilation, ventilator generated an O2 Sensor failure alarm while connecting to an O2 concentrator. Patient's saturation decreased to unknown level. The ventilator was replaced.Final patient outcome was no harm.Manufacturer's Ref.#: (b)(4).
Patient problems: Low Oxygen Saturation
MAUDE report 50894406 ↗MalfunctionSep 24, 2026Mechanical Problem; Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884408 ↗MalfunctionSep 24, 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 50884403 ↗MalfunctionSep 24, 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 50880938 ↗MalfunctionSep 24, 2026Failure of Device to Self-Test
It was reported that the ventilator failed Internal leakage test with a message 'System volume too large' during Pre-use Check. There was no patient involvement.Manufacturer's Ref. #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880049 ↗MalfunctionJun 29, 2026Leak/Splash
IT WAS REPORTED THAT THE VENTILATOR HAD A LEAKAGE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25649997 ↗MalfunctionJun 22, 2026Contamination; Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW TRANSDUCER TEST DURING PRE-USE CHECK. MOREOVER, THE AIR GAS MODULE WAS CONTAMINATED WITH WATER. THERE WAS NO PATIENT HARM.MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25576675 ↗MalfunctionJun 22, 2026Failure of Device to Self-Test
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 25576373 ↗MalfunctionJun 19, 2026Mechanical Problem; Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE 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 25558134 ↗MalfunctionJun 18, 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 REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25545205 ↗MalfunctionJun 18, 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 25543175 ↗MalfunctionJun 18, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED THE INTERNAL LEAKAGE 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 25542470 ↗MalfunctionJun 16, 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 25516187 ↗MalfunctionJun 12, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM OF LOW O2 CONCENTRATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25486098 ↗MalfunctionJun 9, 2026Improper Flow or Infusion
IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR O2 CONCENTRATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25439397 ↗MalfunctionJun 8, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST, PRESSURE TRANSDUCER TEST, SAFETY VALVE TESTS, O2 CELL/SENSOR TEST, FLOW TRANSDUCER TEST AND PATIENT CIRCUIT 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 25428993 ↗MalfunctionJun 3, 2026Gas/Air Leak
IT WAS REPORTED THAT THERE WAS CONTINUOUS GAS LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25369863 ↗MalfunctionJun 2, 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 25358545 ↗MalfunctionJun 2, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING DISABLED VALVES. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25357210 ↗MalfunctionJun 1, 2026Mechanical Problem; Gas/Air Leak
IT WAS REPORTED THAT THE VENTILATOR HAD CONTINUOUS GAS LEAKAGE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25353475 ↗MalfunctionMay 26, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST AND 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 25276053 ↗MalfunctionMay 24, 2026Gas/Air Leak
IT WAS REPORTED THAT THE VENTILATOR HAD A CONTINUOUS GAS LEAK. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266738 ↗
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 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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