Quantum QVM2-D-HMRecalls & reported problems
Spectrum Medical Limited · Quantum Ventilation Module - DISS (Hook Mount) · Class 2
Quick summary
This Quantum QVM2 ventilation module is a hook-mounted gas control unit used during cardiopulmonary bypass to help manage the patient's breathing. The reports mostly describe gas output and suction problems, alarms that would not clear, and pressure and carbon dioxide readings drifting far from the values measured by other equipment, sometimes forcing staff to swap in another device mid-procedure. There are 37 reports, with no deaths and no injuries. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 05060434422071), received between Jul 5, 2024 and Jun 8, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Gas Output Problem” (12 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
- Gas Output Problem12
- Suction Problem4
- Incorrect Measurement3
- Decrease in Pressure2
- Device Sensing Problem2
- Imprecise or Erratic Results2
- Pressure Problem2
- Sensing Intermittently2
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Low Oxygen Saturation1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Gas Output Problem
NOMOLINE ICON FLASHING RED AFTER CPB INITIATION WHEN THEY TRIED SYNCING THE FIRST BLOOD GAS AT 10:37. PIPELINE PROTECTOR CHANGED BUT CONTINUED ALARMING. NOMOLINE REPLACED WITH NEW DISPOSABLE BUT ALARMING CONTINUED. USER ATTEMPTED TO USE OUTSIDE SUCTION ON THE NOMOLINE PORT ON THE QVM2, TO SEE IF ANY CONDENSATION COULD BE REMOVED FROM THE PORT ITSELF. NO RESOLUTION. UNPLUGGED/REPLUGGED NOMOLINE IN MULTIPLE TIMES AND EVEN REPLACED WITH A SECONDARY NOMOLINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428992 ↗MalfunctionJun 8, 2026Gas Output Problem
DURING CASE, PCO2 @37 VALUE TRENDING VERY DANGEROUSLY LOW, DESPITE REPEATED CAPTURE/SYNC. EVEN IMMEDIATELY AFTER PERFORMING A SYNC, PCO2 VALUE WOULD DROP BACK IMMEDIATELY TO HIGH-20S VALUE. USER CHECKED WAG LINE CONNECTIONS, SET SWEEP TO 10 LPM TO BLOW OFF ANY CONDENSATION, AND ALSO EMPTIED THE SPUTUM TRAPS. PIPELINE PROTECTORS WERE REPLACED. FACTORY RESET OF PCO2 WAS NOT PERFORMED, NOR WAS THE NOMOLINE REPLACED AT THE TIME. PCO2 CONTINUED ALARMING BELOW THEIR LOWER LIMIT THRESHOLD THROUGHOUT THE CASE AND REQUIRED SERIAL ABGS TO BE PERFORMED FOR PATIENT SAFETY. ALL OTHER PARAMETERS TRENDED AS NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428946 ↗MalfunctionMar 20, 2026Incorrect Measurement
USER REPORTED AN ERROR WITH THE PRESSUREMENT MEASUREMENT ON THE VENTILATION MODULE. THE VALUE FROM THE PRESSURE SENSOR DID NOT MATCH AN EXTERNAL PRESSURE SENSOR. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650378 ↗MalfunctionMar 20, 2026Incorrect Measurement
USER REPORTED AN ERROR WITH THE PRESSURE MEASUREMENT ON THE VENTILATION MODULE. THE VALUE MEASURED BY THE SENSOR PRESSURE DID NOT MATCH THE EXTERNAL PRESSURE SENSOR. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650276 ↗MalfunctionMar 19, 2026Sensing Intermittently
USER REPORTED THAT THE SAFE LEVEL WAS INTERMITTENTLY INOPERABLE THROUGHOUT THE PROCEDURE. THIS COULD RESULT IN POTENTIAL PATIENT HARM IF SAFE FLOW WAS INACTIVE WHEN EXPECTED TO ENGAGE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641554 ↗MalfunctionMar 18, 2026Gas Output Problem
USER REPORTED THAT THE VENTILATION MODULE ISA FAILED, RESULTING IN HARDWARE ERRORS DURING THE PROCEDURE. THERE WAS NO PATIENT HARM; HOWEVER, THE DEVICE MALFUNCTIONED AND SPECTRUM MEDICAL CONSIDERS THIS EVENT TO BE REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632325 ↗MalfunctionMar 18, 2026Gas Output Problem
USER REPORTED THAT THE VENTILATION MODULE MALFUNCTIONED, CAUSING AN INTERRUPTION IN SWEEP. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626507 ↗MalfunctionMar 12, 2026Incorrect Measurement
USER REPORTED INACCURATE PRESSURE MEASUREMENT FROM PRESSURE SENSOR. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580312 ↗MalfunctionJan 19, 2026Unexpected Shutdown
USER REPORTED THAT THE VENTILATION MODULE TURNED OFF TWICE DURING USE, WHICH IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24109422 ↗MalfunctionDec 19, 2025Pressure Problem; Pressure Problem
USER REPORTED THE INABILITY TO REGULATE THE VACUUM PRESSURE. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS THIS TYPE OF EVENT TO BE REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850405 ↗MalfunctionDec 18, 2025Decrease in Pressure; Decrease in Pressure
USER REPORTED THAT VACUUM REGULATION WAS LOST DURING THE PROCEDURE. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS THE INABILITY TO REGULATE VACUUM TO BE REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838939 ↗MalfunctionDec 18, 2025Decrease in Pressure; Decrease in Pressure
USER REPORTED THAT VACUUM REGULATION WAS LOST DURING THE PROCEDURE. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS THE INABILITY TO REGULATE VACUUM TO BE REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838791 ↗MalfunctionDec 12, 2025Device Sensing Problem; Device Sensing Problem
USER REPORTED THAT THE LEVEL SENSOR DID NOT TRIGGER AN ALERT TO INDICATE A LACK OF FLUID. THIS TYPE OF EVENT IS CONSIDERED REPORTABLE AS THERE IS THE POTENTIAL FOR SERIOUS PATIENT HARM TO OCCUR IF THE RESERVOIR LEVEL WERE TO BE EMPTIED WITHOUT THE USER REALIZING. THERE WAS NO PATIENT HARM IN THIS INSTANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789006 ↗MalfunctionDec 11, 2025Gas Output Problem; Gas Output Problem
USER REPORTED THAT ALTHOUGH THE PO2 MEASUREMENT WAS IN THE 300S ON THE DEVICE, ANOTHER THIRD-PARTY DEVICE SHOWED THAT THE PO2 HAD DROPPED SIGNIFICANTLY.
Patient problems: Low Oxygen Saturation
MAUDE report 23778353 ↗MalfunctionOct 22, 2025Pressure Problem; Pressure Problem
USER REPORTED AN ISSUE WITH THE VENTILATION MODULE VENTING TO ATMOSPHERE TO PREVENT PRESSURE BUILD-UP. THERE WAS NO PATIENT HARM; HOWEVER, THIS ISSUE COULD CREATE A RISK TO THE PATIENT / USER IF THIS WERE TO PERSIST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356189 ↗MalfunctionOct 17, 2025Gas Output Problem; Gas Output Problem
USER REPORTED SWEEP WOULD NOT CHANGE FROM ZERO. THIS IS CONSIDERED REPORTABLE PER SPECTRUM MEDICAL'S CRITERIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23326315 ↗MalfunctionAug 8, 2025Suction Problem; Suction Problem
USER REPORTED ISSUES DURING THE CASE REGULATING THE VACUUM. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750088 ↗MalfunctionAug 7, 2025Suction Problem; Suction Problem
THE PERFUSIONIST REPORTED THE INABILITY TO ADJUST THE VACUUM DURING THE PROCEDURE. THE ISSUE WAS ABLE TO BE RESOLVED AND THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS THIS TYPE OF EVENT TO BE REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737865 ↗MalfunctionAug 6, 2025Device Sensing Problem; Device Sensing Problem
THE LEVEL SENSOR WAS TRIGGERING INAPPROPRIATELY WHEN THERE WAS SUFFICIENT VOLUME IN THE RESERVOIR. SPECTRUM MEDICAL CONSIDERS THIS TO BE A REPORTABLE EVENT DESPITE THERE BEING NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726692 ↗MalfunctionMay 29, 2025Gas Output Problem; Gas Output Problem
USER REPORTED THEY WERE UNABLE TO CHANGE SWEEP SET POINT AND RECEIVED A HARDWARE ERROR. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22111630 ↗MalfunctionMay 20, 2025Inaccurate Delivery; Inaccurate Delivery
USER REPORTED THAT SET-POINTS FOR SWEEP WERE NOT BEING MET. USER WAS ABLE TO RESOLVE ISSUE AND USE THE DEVICE SUCCESSFULLY SINCE THIS EVENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055347 ↗MalfunctionMay 19, 2025Suction Problem; Suction Problem
USER REPORTED INABILITY TO REGULATE VACUUM. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045854 ↗MalfunctionMay 1, 2025Gas Output Problem; Gas Output Problem
INITIALLY THE USER REPORTED "ISSUES" WITH PCO2 VALUES. SERVICE TEAM CHECKED THE VENTILATION MODULE, CALIBRATED AND DOWNLOADED THE LOGS, AND FOUND NO FAULTS. USER THEN REPORTED THAT THEY WERE NOT GETTING AIRFLOW AT THE OUTLET. SERVICE MADE A VISIT TO THE HOSPITAL AND CONFIRMED LACK OF FLOW. THE SERVICE TEAM WAS REQUESTED TO REPLACE THE QVM AND CONDUCT TESTS. USER REPORTED THAT AFTER QVM WAS REPLACED THERE WERE NO FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941108 ↗MalfunctionMar 7, 2025Sensing Intermittently; Sensing Intermittently
INTERMITTENT COMMUNICATION WITH FLOW SENSORS CAUSED UNINTENDED PUMP SLOWING OR STOPPING. THERE WAS NO PATIENT HARM AND THE FAULT WAS DURING VALIDATION; HOWEVER, SPECTRUM MEDICAL CONSIDERS A PUMP STOP TO BE A REPORTABLE EVENT DUE TO THE POTENTIAL EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546389 ↗MalfunctionJan 31, 2025Improper Flow or Infusion; Improper Flow or Infusion
THIS VMSR REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODULE QVM2 (PART NUMBER: 51-000082-00) EXPERIENCED AN ISSUE WHEN REGULATING GAS SWEEP. THERE WAS NO PATIENT HARM ASSOCIATED WITH THESE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21282762 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.