Quantum QVM4-D-HMRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05060434422859), received between Sep 11, 2024 and May 1, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (11 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Gas Output Problem

  USER REPORTED THAT THE SWEEP WENT TO ZERO WITHOUT ANY INDICATION TO THE CLINICIAN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056112 ↗
• MalfunctionApr 16, 2026Calibration Problem

  THE USER REPORTED INACCURATE MEASUREMENTS DISPLAYED ON THE SYSTEM AND INSTABILITY OF THE SYSTEM TO REACH THE SETPOINT. THIS BEHAVIOR IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896428 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  USER REPORTED INCORRECT MEASUREMENTS FROM THE SAMPLE LINE ON THE QUANTUM VENTILATION MODULE. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF INACCURATE MEASUREMENT IS CONSIDERED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727614 ↗
• MalfunctionMar 23, 2026Device Sensing Problem

  THE USER REPORTED GAS FLOW ISSUES THAT CAUSE THE PATIENT'S OXYGEN SATURATION TO DROP, REQUIRING CLINICAL INTERVENTION TO RE-STABILIZE PATIENT LEVELS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24660975 ↗
• MalfunctionFeb 12, 2026Gas Output Problem

  USER REPORTED THAT SWEEP DROPPED TO ZERO UNEXPECTEDLY. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF ISSUE IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322745 ↗
• MalfunctionDec 22, 2025Gas Output Problem; Gas Output Problem

  USER REPORTED THAT THE DEVICE WOULD NOT ALLOW THE USER TO BLEND IN SWEEP GAS. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864457 ↗
• MalfunctionSep 5, 2025Gas Output Problem; Gas Output Problem

  USER REPORTED THAT THE SWEEP REVERTED TO ZERO AFTER CHANGING THE SETPOINT. THERE WAS NO PATIENT HARM; HOWEVER, INTERRUPTION TO SWEEP IS CONSIDERED REPORTABLE BY SPECTRUM MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976311 ↗
• MalfunctionJun 12, 2025Gas Output Problem; Gas Output Problem

  USER REPORTED THAT THE DEVICE WAS NOT DELIVERING OXYGEN, WHICH WAS IDENTIFIED DURING SET-UP. WHILE THERE WAS NO PATIENT HARM, IF THE ERROR WERE TO RECUR DURING A CASE, IT COULD RESULT IN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194897 ↗
• MalfunctionJan 30, 2025Failure to Sense; Failure to Sense

  USER REPORTED THE QUANTUM VENTILATION MODULE READING A NEGATIVE PRESSURE INCORRECTLY. INCORRECT MEASUREMENT FROM A LEVEL SENSOR IS CONSIDERED A REPORTABLE MALFUNCTION. THERE WAS NO PATIENT HARM DUE TO THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272134 ↗
• MalfunctionDec 9, 2024Gas Output Problem; Gas Output Problem

  CUSTOMER IDENTIFIED A SETPOINT ERROR WHEN EXCEEDING A SWEEP OF 1 LPM DURING A CASE AND CLINICIAN REBOOTED THE MODULE TO ADDRESS THE ERROR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878088 ↗
• MalfunctionDec 5, 2024Gas Output Problem; Gas Output Problem

  VENT MODULE IDENTIFIED A HARDWARE ERROR AND USER WAS UNABLE TO SET SWEEP GAS FLOW RATE. USER PERFORMED HARD REBOOT OF DEVICE, WHICH RESOLVED THE ERROR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853737 ↗
• MalfunctionNov 28, 2024Gas Output Problem; Gas Output Problem

  PERFUSIONIST REPORTED THAT THE LEVELS OF SWEEP AND FIO2 WERE RAPIDLY FLUCTUATING DURING A CASE. A BACKUP WAS USED TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER INABILITY TO MANAGE GAS FLOW TO BE A REPORTABLE EVENT, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805694 ↗
• MalfunctionNov 28, 2024Gas Output Problem; Gas Output Problem

  PERFUSIONIST REPORTED THAT THAT THEY WERE UNABLE TO CHANGE THE VALUE FOR SWEEP. WE CONSIDER THE LOSS OF ABILITY TO CONTROL GAS MANAGEMENT TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804291 ↗
• MalfunctionNov 27, 2024Gas Output Problem; Gas Output Problem

  PERFUSIONIST REPORTED THAT THEY WERE UNABLE TO CONTROL THE SWEEP DURING A CASE. WE CONSIDER INABILITY TO MANAGE GAS FLOW TO BE A REPORTABLE EVENT, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796542 ↗
• MalfunctionNov 11, 2024Failure to Calibrate; Failure to Calibrate

  PERFUSIONIST REPORTED THAT THE GAS CALIBRATION FAILED. FOLLOWING THIS, ERROR MESSAGES APPEARED REPEATEDLY, INCLUDING WHEN THE SPECIALIST ATTEMPTED TO INCREASE THE FLOW. THERE WAS NO HARM TO THE PATIENT INVOLVED, DESPITE SWITCHING TO A DIFFERENT GAS MANAGEMENT SYSTEM. WE CONSIDER THE LOSS OF ABILITY TO CONTROL GAS MANAGEMENT TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650135 ↗
• MalfunctionOct 29, 2024Gas Output Problem; Gas Output Problem

  ERROR CODES 2883 AND 2884 DISPLAYED. THE PERFUSIONIST WAS UNABLE TO ADJUST SWEEP AND FIO2. AS GAS FLOW WAS INTERRUPTED, THIS IS CONSIDERED A REPORTABLE EVENT. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20555881 ↗
• MalfunctionOct 25, 2024Electrical /Electronic Property Problem; Incorrect Interpretation of Signal; Electrical /Electronic Property Problem; Incorrect Interpretation of Signal

  USER REPORTED THAT THEY WERE EXPERIENCING ISSUES WITH NOMOLINE READING EITHER SHOWING "0" OR ">180". THIS IS BELIEVED TO BE AN INCORRECT MEASUREMENT FROM THE SENSOR. ALSO OF NOTE THE VENTILATION MODULE SHOWED "HARDWARE ERROR (2881)" FOR BOTH PCO2 AND PO2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532437 ↗
• MalfunctionSep 11, 2024Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT DURING A CASE A PACO2 READING WAS FLUCTUATING BETWEEN READING CORRECTLY AND THEN DROPPING TO 0 FOR AN EXTENDED PERIOD. PAO2 ALSO BEGAN READING "!!!". THE USER TRIED REPLACING THE NOMOLINE AND DRYING OUT THE PORT ON THE QVM4 WHERE THE NOMOLINE IS ATTACHED USING A FAN FOR OVER 8 HOURS BUT THE READING NEVER RECOVERED, AND THE PATIENT WAS TAKEN OFF THE PUMP THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189619 ↗