qube 91390Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10841522100550), received between Jul 25, 2024 and Mar 2, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (12 reports).

9 other recalls cover devices cleared under the same FDA submission (K120616); 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT A QUBE COMPACT MONITOR UNEXPECTEDLY SHUT DOWN AND NO LONGER POWERS UP. NO PATIENT OR USER HARM WAS REPORTED. THE DEVICE WAS RETURNED TO SPACELABS HEALTHCARE FOR EVALUATION, AND THE ISSUE WAS VERIFIED. THE CAUSE OF THE ISSUE WAS FOUND TO BE THE CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE PCBA WAS REPLACED TO RESOLVE THE ISSUE. AFTER FUNCTIONAL AND PERFORMANCE TESTING WAS PERFORMED, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484336 ↗
• MalfunctionMar 2, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT A QUBE COMPACT MONITOR SHUT DOWN WHILE MONITORING A PATIENT. NO PATIENT OR USER HARM WAS REPORTED. THE DEVICE WAS RETURNED TO SPACELABS HEALTHCARE FOR EVALUATION, AND THE QUBE WOULD NOT POWER ON. THE CPU PCBA WAS REPLACED AND AFTER FUNCTIONAL AND PERFORMANCE TESTING WAS PERFORMED, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484248 ↗
• MalfunctionFeb 19, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT THEIR QUBE BEDSIDE MONITOR WAS INTERMITTENTLY REBOOTING ITSELF. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER'S DEVICE WAS RETURNED TO SPACELABS HEALTHCARE FOR EVALUATION, AND THE REPORTED ISSUE WAS VERIFIED. THE CENTRAL PROCESSING UNIT PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED. AFTER FUNCTIONAL AND PERFORMANCE TESTING WAS PERFORMED, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397728 ↗
• MalfunctionFeb 5, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT A QUBE COMPACT MONITOR SHUT DOWN WHILE MONITORING A PATIENT. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PATIENT WAS MOVED TO A DIFFERENT BED FOR CONTINUED MONITORING AND THE DEVICE IN QUESTION WAS TAKEN OUT OF USE. THE CAUSE OF THE ISSUE WAS UNKNOWN AS THE CUSTOMER DECLINED FURTHER SERVICE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274863 ↗
• MalfunctionJan 21, 2026Communication or Transmission Problem

  THE CUSTOMER REPORTED TO SPACELABS HEALTHCARE THAT THE QUBE MONITOR SHUTS DOWN WHEN THE DEVICE IS MOVED. NO PATIENT OR USER HARM WAS REPORTED. THE DEVICE WAS RETURNED TO SPACELABS HEALTHCARE WHERE THE EQUIPMENT SERVICE CENTER FOUND A FAULTY SDLC PCBA. THE DEVICE WAS REPAIRED AND FOLLOWING ALL FUNCTIONAL TESTING, WAS RETURNED TO THE CUSTOMER FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141442 ↗
• MalfunctionJan 16, 2026Unexpected Shutdown

  IT WAS REPORTED TO SPACELABS HEALTHCARE THAT A QUBE COMPACT MONITOR WOULD RANDOMLY TURN OFF AND RESTART. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RECEIVED BY SPACELABS HEALTHCARE FOR EVALUATION BUT THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24104854 ↗
• MalfunctionDec 8, 2025Power Problem; Power Problem

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT A XPREZZON BEDSIDE MONITOR THAT SHUT DOWN WHILE MONITORING A PATIENT DURING A SURGERY. THE CUSTOM REQUESTED A RETURN AUTHORIZATION TO RETURN THE FAULTY UNIT. AT THIS TIME THE DEVICE HAS NOT BEEN RECEIVED BY SPACELABS HEALTHCARE FOR FURTHER EVALUATION AND REPAIR. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23738747 ↗
• MalfunctionNov 20, 2025Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT THE SCREEN ON THEIR QUBE COMPACT MONITOR WOULD FREEZE AND UNEXPECTEDLY SHUT DOWN WHEN THE MONITOR WAS MOVED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. THE CUSTOMER RETURNED THEIR MONITOR TO THE EQUIPMENT SERVICE CENTER (ESC) FOR EVALUATION. AN ESC TECHNICIAN EVALUATED THE DEVICE WHERE THEY WERE ABLE TO VERIFY THE REPORTED ISSUE OF THE DEVICE SHUTTING DOWN, BUT THEY WERE UNABLE TO VERIFY THE REPORTED FREEZING DISPLAY. FURTHER EVALUATION OF THE DEVICE SHOWED THAT THE CAUSE OF THE REPORTED POWER ISSUE WAS DUE TO A FAULTY CPU PCBA. AFTER REPLACEMENT OF THE CPU PCBA, PROPER DEVICE OPERATION WAS OBSERVED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. THE CAUSE OF THE REPORTED POWER ISSUE WAS DUE TO A FAULTY CPU PCBA. THE CAUSE OF THE REPORTED SCREEN FREEZING ISSUE COULD NOT BE DETERMINED, AS THE ISSUE COULD NOT BE DUPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609585 ↗
• MalfunctionAug 28, 2025Complete Loss of Power; Complete Loss of Power

  THE CUSTOMER REPORTED THAT WHILE MONITORING A PATIENT, THE QUBE BEDSIDE MONITOR SUDDENLY SHUT DOWN. IT WAS CONFIRMED THAT THE QUBE BEDSIDE MONITOR EMITTED THE POWER SAFE ALARM THAT NOTIFIED THE STAFF OF THE ISSUE. THE CLINICIAN ADMITTED THE PATIENT TO A REPLACEMENT MONITOR AND SUBMITTED THE DEVICE TO THE INTERNAL BIOMED TEAM FOR REPAIR. IN A FOLLOW UP CALL, THE CUSTOMER BIOMED CONFIRMED THAT THE ISSUE WITH THE MONITOR WAS RESOLVED, HOWEVER DETAILS WERE UNKNOWN AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT IF THEY LEARNED OF ADDITIONAL INFORMATION, THEY WOULD FORWARD THE ADDITIONAL DETAILS. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917285 ↗
• MalfunctionAug 8, 2025No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT WHILE TRANSPORTING A PATIENT, A QUBE BEDSIDE MONITOR DISPLAY TURNED OFF WHEN THE PORTABLE STAND WAS BUMPED. USERS POWER CYCLED THE DEVICE AND MOVED THE BATTERY TO A DIFFERENT BATTERY SLOT AND STATED THE DEVICE WAS ABLE TO RESUME MONITORING. DURING TROUBLESHOOTING THE ISSUE, IT COULD NOT BE DETERMINED IF THE ISSUE WAS LIMITED TO THE DISPLAY ONLY, OR IF THERE WAS A COMPLETE POWER LOSS. THE CUSTOMER REPORTED THAT A BIOMED EVALUATED THE DEVICE AND COULD NOT FIND ANY FAULTS WITH THE DEVICE. THE UNIT HAS BEEN PUT BACK IN USE WITH NO FURTHER ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755866 ↗
• MalfunctionJun 30, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT A QUBE BEDSIDE MONITOR GOT STUCK IN A BOOT LOOP WHILE MONITORING A PATIENT. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE FAULTY DEVICE WAS SHIPPED TO SPACELABS HEALTHCARE FOR DEPOT REPAIR. THE DEVICE WAS RECEIVED AND EVALUATED BY AN EQUIPMENT SERVICE CENTER TECHNICIAN AND THE REPORTED PROBLEM WAS VERIFIED. THE FAILURE WAS TRACED DOWN TO A FAULTY CPU PCBA. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352735 ↗
• MalfunctionJun 30, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT WHILE IN USE A QUBE BEDSIDE MONITOR WOULD OCCASSIONALLY RESET AND REQUESTED EVALUATION AND REPAIR. CUSTOMER SERVICE MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER TO GENERATE A RMA TO HAVE THE DEVICE RETURNED FOR REPAIR. AT THIS TIME, THE CUSTOMER HAS NOT RESPONDED AND THE DEVICE HAS NOT BEEN RECEIVED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352698 ↗
• MalfunctionJun 20, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER BIOMED REPORTED THAT WHILE MONITORING A PATIENT, A QUBE BEDSIDE MONITOR SHUT DOWN. THE CUSTOMER REPORTED THE POWER LOSS ALARM FUNCTIONED TO NOTIFY CLINICAL STAFF OF THE SUDDEN SHUT DOWN AND THE PATIENT WAS MOVED TO ANOTHER ROOM. THE BIOMED STATED THE MONITOR WAS PLUGGED INTO AC MAINS AND THAT THE QUBE HAD A BATTERY INSIDE THAT WAS FULLY CHARGED. THE BIOMED ALSO REPORTED THAT THE MONITOR WOULD POWER DOWN WHEN THE BATTERY WAS REMOVED, EVEN WHILE CONNECTED TO MAINS. THE CUSTOMER STATED THAT THEY WOULD SHIP THE DEVICE IN FOR DEPOT REPAIR. AT THIS TIME, THE CUSTOMER HAS NOT OPENED A RMA TO SEND THE DEVICE IN FOR FURTHER EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294658 ↗
• MalfunctionMay 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REQUEST A SERVICE REPAIR FOR A QUBE BEDSIDE MONITOR THAT HAD THE FOLLOWING ISSUE: EVERYTIME THE COMMAND MODULE IS PRESSED IN, THE VITALS WOULD DISAPPEAR. THE CUSTOMER ALSO REPORTED THAT THEY OBSERVED THAT A PORTION OF THE MODULE CONNECTION APPEARED TO HAVE BURNT/DARK MARKS. THE UNIT WAS RECEIVED BY SPACELABS AND THE TECHNICIAN STATED THAT THE DEVICE WOULD NOT BOOT UP DUE TO A FAULTY CPU PCBA. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038255 ↗
• MalfunctionMay 8, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT A CUBE BEDSIDE MONITOR SHUT DOWN WHILE IN USE. A SPACELABS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO ATTEMPT TO RELOAD THE SOFTWARE OF THE DEVICE, HOWEVER THE DEVICE WOULD NOT ACCEPT THE SOFTWARE RELOAD. THE FSE OPENED A RMA TO SHIP THE UNIT IN FOR FURTHER EVALUATION. AT THIS TIME THE UNIT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990956 ↗
• MalfunctionApr 18, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT WHILE MONITORING A PATIENT, A QUBE BEDSIDE MONITOR WOULD INTERMITTENTLY SHUT ITSELF OFF. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867967 ↗
• MalfunctionJan 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT WHILE IN USE, THE QUBE BEDSIDE MONITOR WOULD INTERMITTENTLY LOSE PATIENT MONITORING. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284087 ↗
• MalfunctionJan 17, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT WHILE IN USE, THE QUBE BEDSIDE MONITOR REBOOTED ON ITS OWN TWICE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180702 ↗
• MalfunctionDec 13, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT WHILE IN USE, THEIR QUBE BEDSIDE MONITOR WOULD INTERMITTENTLY REVERT TO THE BOOT SCREEN. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921714 ↗
• MalfunctionOct 11, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT WHILE IN USE, THE QUBE BEDSIDE MONITOR WOULD RANDOMLY SHUT DOWN. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434470 ↗
• MalfunctionJul 25, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT WHILE MONITORING A PATIENT A QUBE BEDSIDE MONITOR SHUT DOWN ON ITS OWN. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834236 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120616. One submission often covers many models, so check the product and lot details in each record.

• Z-0167-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to D
• Z-0169-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to
• Z-0168-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to
• Z-1608-2015 · May 8, 2015 · Terminated
  Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter
• Z-1145-2015 · Jan 28, 2015 · Terminated
  Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displ
• Z-1852-2014 · Jun 6, 2014 · Terminated
  Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other phy
• Z-0351-2014 · Oct 17, 2013 · Terminated
  Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervi
• Z-0188-2014 · Oct 17, 2013 · Terminated
  Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
• Z-0403-2013 · Oct 19, 2012 · Terminated
  qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.