Servo-air Lite 6893200Recalls & reported problems
Maquet Critical Care AB · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Maquet Servo-air Lite ventilator is a floor-standing machine that provides breathing support in hospitals. The 39 reports mostly describe the unit failing its own pre-use self-checks and generating error codes or alarms, along with flow and turbine problems, with no patient harm mentioned. There are 39 malfunctions, no deaths and no injuries. No recalls name this device, and reports rose from 14 to 24 over the past 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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07325710015117), received between Sep 27, 2024 and Sep 29, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (24 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-Test24
- Output Problem7
- Infusion or Flow Problem6
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure of Device to Self-Test
It was reported that the ventilator failed the Pressure transducer 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 50932413 ↗MalfunctionJun 24, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE 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 25606173 ↗MalfunctionJun 17, 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 25530379 ↗MalfunctionJun 2, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT 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 25359404 ↗MalfunctionMay 24, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR HAD A TURBINE FAILURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266734 ↗MalfunctionMay 20, 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 25229095 ↗MalfunctionMay 19, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT 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 25213995 ↗MalfunctionMay 19, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT 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 25213994 ↗MalfunctionMay 14, 2026Infusion or Flow Problem
IT WAS REPORTED THAT 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 25174931 ↗MalfunctionApr 29, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE VENTILATOR HAD ISSUES WITH DELIVERY OF AIR FLOW. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024466 ↗MalfunctionApr 17, 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 24908745 ↗MalfunctionApr 14, 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 24870776 ↗MalfunctionApr 9, 2026Improper Flow or Infusion
IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS INDICATING A O2 CONCENTRATION LOW, CHECK TUBING AND LEAKAGE TOO HIGH. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24827692 ↗MalfunctionMar 23, 2026Failure of Device to Self-Test
MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663228 ↗MalfunctionFeb 27, 2026Failure of Device to Self-Test
MANUFACTURER'S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469702 ↗MalfunctionFeb 27, 2026Failure of Device to Self-Test
MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468672 ↗MalfunctionFeb 27, 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 24468601 ↗MalfunctionFeb 16, 2026Failure of Device to Self-Test
MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344172 ↗MalfunctionJan 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 24187806 ↗MalfunctionJan 23, 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 24159304 ↗MalfunctionJan 21, 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 24127589 ↗MalfunctionJan 20, 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 24113089 ↗MalfunctionOct 31, 2025Failure of Device to Self-Test; Failure 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 23434559 ↗MalfunctionOct 31, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR TURBINE FAILURE. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23434490 ↗MalfunctionOct 29, 2025Failure of Device to Self-Test; Failure 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 23411562 ↗
Other Ventilator, Continuous, Minimal Ventilatory Support, Facility Use devices
- Philips Respironics V60Respironics California, Inc. · Ventilator, Continuous, Minimal Ventilatory Support,Facility Use3 recalls30 deaths13,525 reports
- PHILIPS 1076716Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death2,946 reports
- PHILIPS 1076709Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use8 deaths2,174 reports
- PHILIPS 1053614Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls4 deaths1,203 reports
- BiPAP A40 EEX3100S19Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls422 reports
- BiPAP A40 DEX3100S13Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls164 reports
- BiPAP A40 ITX3100S21Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls163 reports
- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 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 13, 2026
- 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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