Servo-i Base Unit 6487800Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Maquet Servo-i ventilator is a breathing machine used in medical facilities. Its 835 reports include 4 deaths and 18 injuries. Many describe the ventilator failing its pre-use self-tests, such as leakage or pressure checks, and some describe power errors; many report no patient involvement. Reports fell to 190 in the last 12 months, down from 313 in the 12 months before. No recalls name this device.
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
- 832
- Deaths reported
- 4
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 832 adverse event reports that list this exact device (DI 07325710000823), received between Aug 16, 2022 and Sep 30, 2026 — classified as 4 deaths, 16 injuries, 812 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (378 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure of Device to Self-Test378
- Output Problem342
- Mechanical Problem56
- Infusion or Flow Problem54
- Contamination47
- Fracture13
- Power Problem10
- Increase in Pressure9
Patient problems
- No Clinical Signs, Symptoms or Conditions812
- Low Oxygen Saturation12
- Insufficient Information4
- Bradycardia2
- Hypercalcemia2
- Hyperventilation2
- Hypoventilation2
Recent adverse event reports
The 25 most recent of 832 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 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 50945957 ↗MalfunctionSep 29, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932645 ↗MalfunctionSep 28, 2026Mechanical Problem; Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916750 ↗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 50896059 ↗MalfunctionSep 25, 2026Fracture
It was reported that the ventilator's support arm was broken. There was no patient involvement. Manufacturer's Ref. #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895629 ↗MalfunctionSep 25, 2026Output Problem; Power Problem
During the inspection of the ventilator it was discovered that a technical error code indicating power error was generated. Moreover, according to provided device's logs, technical error code indicating an open safety valve was also generated.There was no patient involvement. Manufacturer's Ref. #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894836 ↗MalfunctionJun 30, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED TECHNICAL ERROR CODE INDICATING POWER ERROR. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662592 ↗MalfunctionJun 29, 2026Contamination /Decontamination Problem; Failure of Device to Self-Test
IT WAS REPORTED THAT 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 25649247 ↗MalfunctionJun 25, 2026Contamination; Power Problem
IT WAS REPORTED THAT THE VENTILATOR HAD POWER SUPPLY ISSUE. DURING THE INSPECTION OF THE VENTILATOR, LIQUID WAS OBSERVED ON THE AC/DC PRINTED CIRCUIT BOARD. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626878 ↗MalfunctionJun 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 25606085 ↗MalfunctionJun 22, 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 25585898 ↗MalfunctionJun 22, 2026Mechanical Problem; Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST AND 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 25585409 ↗MalfunctionJun 19, 2026Failure of Device to Self-Test; Output Problem
IT WAS REPORTED THAT THE VENTILATOR FAILED FLOW TRANSDUCER TEST AND SAFETY VALVE TEST DURING PRE-USE CHECK. MOREOVER, THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING ERROR IN THE INTERNAL MEMORY. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25558136 ↗MalfunctionJun 18, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING AN OPEN SAFETY VALVE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25545979 ↗MalfunctionJun 16, 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 25517471 ↗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 25514141 ↗MalfunctionJun 11, 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 25467915 ↗MalfunctionJun 10, 2026Electrical /Electronic Property Problem
DURING ON-SITE VISIT IT WAS DISCOVERED THAT CONTROL PRINTED CIRCUIT BOARD HAS BEEN DEFECTIVE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453484 ↗MalfunctionJun 2, 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 25359399 ↗MalfunctionJun 2, 2026Contamination /Decontamination Problem; Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PR-USE CHECK. FURTHERMORE, THE AIR GAS MODULE WAS CONTAMINATED WITH WATER. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURE'S REF.#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25357474 ↗MalfunctionJun 1, 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 25353987 ↗MalfunctionJun 1, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT INTERNAL LEAKAGE AND SAFETY VALVE TESTS FAILED DURING PRE-USE CHECK. NO PATIENT INVOLVEMENTS. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25346483 ↗MalfunctionMay 27, 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 25298120 ↗MalfunctionMay 26, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED SEVERAL TESTS 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 25277121 ↗MalfunctionMay 24, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED GAS SUPPLY 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 25266736 ↗
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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page