GarbinRecalls & reported problems across all models
Respironics, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 77
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Garbin by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2015 and Jun 18, 2026 — classified as 1 death, 76 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (40 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Garbin problems
Device problems
- Device Displays Incorrect Message40
- Battery Problem24
- Failure to Charge6
- Device Operational Issue5
- Device Operates Differently Than Expected4
- Circuit Failure3
- Calibration Problem2
- Computer Software Problem2
Patient problems
- No Patient Involvement63
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient3
- Cough2
- Headache2
- No Known Impact Or Consequence To Patient2
- Unspecified Respiratory Problem2
- Chest Pain1
Garbin models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Garbin 00Oximeter63 reports
- Garbin Garbin Ventilator, Bluetooth, INTLCONTINUOUS, VENTILATOR, HOME USE1 death14 reports
Recent Garbin adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Electrical /Electronic Property Problem
A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO VENTILATOR INOPERATIVE CONDITION WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. ADDITIONALLY, UNIT STATUS: REMEDIATION REPAIR, ADDITIONAL SERVICE: YES. 10K PM REQUESTED. THE DEVICE WAS CORRECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553434 ↗MalfunctionApr 29, 2026Computer Software Problem
A DEVICE WAS RETURNED TO A SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036027 ↗MalfunctionApr 29, 2026Computer Software Problem
A DEVICE WAS RETURNED TO A SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATED TO AIRSTREAM TEMPERATURE. THE DEVICE HAD A REPAIR TEST TO ADDRESS THE FAILED TEST STEP. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034431 ↗MalfunctionApr 14, 2026Calibration Problem
A DEVICE WAS RETURNED TO A SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. A GARBIN VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE FOAM WAS REPLACED PREVENTATIVELY. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE ACTIVE EXHALATION PURGE VALVE CLOSED TEST STEP. THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE OR A COMPONENT REPLACEMENT. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED. ADDITIONALLY THE DEVICE FAILED A NOT-REPORTABLE TEST STEP RELATING TO CHECK LEAK. THE CUSTOMER REQUESTED THE RETURN OF THE DEVICE UNSERVICED, THEREFORE NO REPAIRS WERE PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873202 ↗MalfunctionApr 10, 2026Calibration Problem
A DEVICE WAS RETURNED TO A SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO POWER CONSUMPTION IN SLEEP MODE WAS IDENTIFIED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844385 ↗MalfunctionJun 6, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE'S MOTOR BLOWER ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, AN ERROR CODE DEPICTING THE INTERNAL BATTERY WAS DEPLETED WAS OBSERVED. THE INTERNAL BATTERY WAS CHARGED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475344 ↗MalfunctionJul 24, 2023Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A PATIENT EXPERIENCED VERTIGO, LIGHTHEADEDNESS, HEADACHE, COUGH, AND CHEST PRESSURE, IRRITATION AND DRYNESS OF THE RESPIRATORY TRACT, NOSE AND EYES WHEN USING A VENTILATOR. IN ADDITION, THE PATIENT ALLEGED EXPERIENCING AN "ACID" SMELL. NO MEDICAL INTERVENTION WAS REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Cough; Headache; Unspecified Respiratory Problem
MAUDE report 17379099 ↗MalfunctionJul 20, 2023Degraded; Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VERTIGO, LIGHTHEADEDNESS, HEADACHE, COUGH, CHEST PRESSURE, IRRITATION AND DRYNESS OF THE RESPIRATORY TRACT, NOSE AND EYES, AS WELL AS SMELLING ACID SMELLS. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Chest Pain; Cough; Eye Irritation; Headache; Unspecified Respiratory Problem; Vertigo
MAUDE report 17361317 ↗MalfunctionMay 2, 2019Circuit Failure; Circuit Failure
A VENTILATOR WAS RETURNED TO THE MANUFACTURE FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 8574393 ↗MalfunctionMar 20, 2019Circuit Failure; Circuit Failure
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 8435855 ↗MalfunctionMar 20, 2019Circuit Failure; Circuit Failure
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 8435851 ↗DeathAug 14, 2018No Audible Alarm; Adverse Event Without Identified Device or Use Problem; No Audible Alarm; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO ALARM WHEN A PATIENT BECAME DISCONNECTED FROM THE VENTILATOR. THE MANUFACTURER'S INVESTIGATION IS CURRENTLY ON-GOING AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Patient problems: Death
MAUDE report 7781731 ↗MalfunctionMar 14, 2018Failure to Power Up; Failure to Power Up
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A FAILURE OF THE DEVICE TO POWER ON WAS OBSERVED. THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 7337458 ↗MalfunctionMar 14, 2018Device Operational Issue; Device Operational Issue
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 7337454 ↗MalfunctionMar 14, 2018Device Operational Issue; Device Operational Issue
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Patient Involvement
MAUDE report 7337453 ↗
Other Respironics, Inc. products
- REMstar System One 60 Series92 models · 37,934 reports
- Philips Trilogy Ventilator90 models · 36,113 reports · 22 recalls
- Philips DreamStation190 models · 32,422 reports
- Trilogy46 models · 21,644 reports · 11 recalls
- Trilogy Evo20 models · 5,473 reports · 12 recalls
- Trilogy 1008 models · 5,088 reports
- BiPAP System One 60 Series40 models · 4,599 reports
- BiPAP A4037 models · 1,606 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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