BASE UNIT SERVO-U 6694800Recalls & 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-U base unit is a ventilator for facility use. Its 652 reports mostly describe alarms, output problems and failures of the device's self-test, with some reports of low oxygen levels in patients. The reports include 2 deaths and 59 injuries. One open recall started in May 2025 over possible inaccurate measurements of the breathing circuit.
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
- 655
- Deaths reported
- 4
- Injuries reported
- 57
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 655 adverse event reports that list this exact device (DI 07325710001110), received between Apr 19, 2018 and Sep 30, 2026 — classified as 4 deaths, 57 injuries, 593 malfunctions.
The most frequently reported specific device problem is “Output Problem” (253 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-2014-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Output Problem253
- Failure of Device to Self-Test140
- Infusion or Flow Problem76
- Contamination42
- Increase in Pressure38
- Fracture22
- Improper Flow or Infusion22
- Tidal Volume Fluctuations15
Patient problems
- No Clinical Signs, Symptoms or Conditions591
- Low Oxygen Saturation45
- Bradycardia8
- Hypoxia8
- Respiratory Failure4
- Hypoventilation2
- Insufficient Information2
- Pulmonary Edema2
Recent adverse event reports
The 25 most recent of 655 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Infusion or Flow Problem
It was reported that the O2 concentration was lower than the set value.There was no patient harm.Manufacturer's Ref #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947114 ↗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 50942939 ↗MalfunctionSep 29, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932643 ↗MalfunctionSep 28, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914459 ↗MalfunctionSep 28, 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 50913870 ↗OtherSep 25, 2026Infusion or Flow Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903896 ↗MalfunctionSep 25, 2026Gas/Air Leak
It was reported that during ventilation issue with delivery of the set volume and low O2 concentration occurred.There was no patient harm.Manufacturer's Ref. #: (b)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895465 ↗MalfunctionSep 25, 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 50894825 ↗MalfunctionSep 24, 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 50880940 ↗DeathSep 21, 2026Device Alarm System
It was reported that the patient experienced a period of significant hypoxaemia that was not recognized. The reported hypoxaemia was associated with hypoventilation, while the ventilator alarms reportedly had been deactivated.The event resulted in loss of life.Manufacturer¿s Ref #: (b)(4).
Patient problems: Hypoxia
MAUDE report 50840658 ↗DeathSep 21, 2026Device Alarm System
It was reported that the patient experienced a period of significant hypoxaemia that was not recognized. The reported hypoxaemia was associated with hypoventilation, while the ventilator alarms reportedly had been deactivated.The event resulted in loss of life.Manufacturer¿s Ref #: (b)(4).
Patient problems: Hypoxia
MAUDE report 50835382 ↗MalfunctionAug 5, 2026Fracture
Manufacturer's Ref. #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50138275 ↗MalfunctionJul 31, 2026Failure of Device to Self-Test
Manufacturer's Ref. #: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50097558 ↗MalfunctionJul 30, 2026Output Problem
Manufacturer ref. no: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081820 ↗MalfunctionJun 26, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25634206 ↗MalfunctionJun 23, 2026Failure of Device to Self-Test; Improper Flow or Infusion
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM INDICATING LOW POSITIVE END EXPIRATORY PRESSURE (PEEP). MOREOVER, DURING THE INSPECTION OF THE VENTILATOR IT WAS DISCOVERED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25591981 ↗MalfunctionJun 19, 2026Output Problem
IT WAS REPORTED THAT THE VENTILATOR EXHIBITED LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25556875 ↗MalfunctionJun 16, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE AND PRESSURE TRANSDUCER TESTS DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25515934 ↗MalfunctionJun 15, 2026Contamination
IT WAS REPORTED THAT THE VENTILATOR'S AIR GAS MODULE WAS CONTAMINATED BY LIQUID. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25499637 ↗MalfunctionJun 11, 2026Failure of Device to Self-Test
IT WAS REPORTED THAT THE VENTILATOR FAILED THE 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 25468674 ↗MalfunctionJun 10, 2026Contamination
IT WAS REPORTED THAT THE VENTILATOR'S AIR GAS MODULE WAS CONTAMINATED BY LIQUID. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25452938 ↗MalfunctionJun 9, 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 25441734 ↗MalfunctionJun 3, 2026Output Problem
IT WAS REPORTED THAT 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 25374336 ↗MalfunctionJun 3, 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 25369865 ↗MalfunctionJun 2, 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 25359171 ↗
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-2015-2025 · May 30, 2025 · Open, ClassifiedServo-u MR Ventilator System. Model Number: 6888800.
- Z-2013-2025 · May 30, 2025 · Open, ClassifiedServo-u Ventilator System. Model Number: 6688600.
- 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.