Vivo 45 LS USRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07321822300004), received between Mar 8, 2023 and Jun 19, 2026 — classified as 6 deaths, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K193586); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jul 25, 2024Open, Classified

   There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.

   Z-2690-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 2, 2022Open, Classified

   A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained

   Z-1382-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathJun 19, 2026Insufficient Device Problem Information

  ON MAY 19, BREAS RECEIVED THE FOLLOWING REPORT: 'BASED ON THE TRIGGERED ALARM FROM 1:20 AM AND GOING BACK 24 HOURS, WAS THE MACHINE WORKING APPROPRIATELY. SPECIFICALLY INTERESTED IN ANY LOW PRESSURE AND DISCONNECTION ALARMS. AT THE GIVEN TIME PERIOD WAS THE VENTILATOR'S AUDIBLE ALARM ACTIVE WITH EACH TRIGGERED ALARM. AND, AFTER 8:33 AM THERE ARE MORE TRIGGERED ALARMS SINCE MACHINE WAS PLACED ON STANDBY? PLEASE NOTE THE DISCREPANCY OF MONITOR DISPLAYED TIME WITH THE ACTUAL TIME PICTURE WAS TAKEN. A DIFFERENCE OF APPROXIMATELY 4:36 MINUTES THAT HAS BEEN SINCE CORRECTED.' ON MAY 22, BREAS WAS INFORMED THAT THE PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 25564255 ↗
• DeathOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2025, AT 6:52 PM ET, PATIENT SUPPORT REP (B)(6) CONTACTED DELIVERY TECHNICIAN (B)(6) ABOUT AN ISSUE WITH PATIENT (B)(6)' (11-YEAR-OLD PATIENT) PULSE OXIMETER. AT 6:58 PM ET, (B)(6) TROUBLESHOT THE DEVICE WITH MOM (B)(6) AND A (B)(6) IN-HOME NURSE. MOM HAD ALREADY CALLED 911 BEFORE CONTACTING AMS. EMERGENCY SERVICES TESTED PATIENTS' VITALS WITH THEIR EQUIPMENT AND CONCLUDED THE PATIENT WAS STABLE AND READINGS FROM (B)(6) EQUIPMENT PROVIDED SIMILAR RESULTS AND HAD LEFT. THE PATIENT WAS REPORTED STABLE AT THIS TIME. (B)(6) PREPARED REPLACEMENT EQUIPMENT AND DEPARTED FOR THE PATIENT'S HOME AT 7:20 PM ET. HE ARRIVED AT 9:20 PM ET, WHERE THE NURSE INFORMED HIM THAT 911 HAD BEEN CALLED AGAIN DURING HIS TRAVEL TIME. (B)(6) EXCHANGED BOTH THE PULSE OXIMETER AND PATIENT CABLE, WITH THE NURSE SIGNING FOR THE EXCHANGE. DURING THIS PROCESS, MOM CALLED THE NURSE AND INFORMED THEM THAT THE PATIENT HAD PASSED AWAY. AT 9:51 PM ET, (B)(6) CONTACTED HIS SUPERVISOR (B)(6), WHO INSTRUCTED HIM TO DOCUMENT THE INCIDENT. (B)(6) SENT DETAILED INFORMATION TO (B)(6). HE ADDED A NOTE TO THE PATIENT'S (B)(4) ACCOUNT, AND THE EQUIPMENT WAS QUARANTINED IN THE WAREHOUSE FOR FURTHER INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 23294715 ↗
• MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  BREAS VENTILATOR BEING USED IN PATIENT HOME. THERAPIST REPORTED THE VENTILATOR WAS NOT PRODUCING A DISCONNECTION ALARM WHEN THEY VISIBLY NOTICED THAT THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR. WHEN THERAPIST ARRIVED AT THE HOME SHE DISCONNECTED THE PATIENT FROM THE VENT AND FOUND THE VENT DID NOT ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292707 ↗
• MalfunctionSep 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  HOME HEALTH PATIENT PARENTS WERE AWAKENED BY THE PULSE OXIMETER ALARMING AND NOTED THAT CHILD WAS DISCONNECTED FROM HIS VENTILATOR. PARENTS NOTED THE VENTILATOR WAS NOT ALARMING DESPITE BEING DISCONNECTED FROM CHILD. MOM STATED IF THE PULSE OXIMETER HAD NOT WOKEN HER AND DAD UP, THEY WOULD HAVE NEVER KNOWN CHILD WAS DISCONNECTED FROM HIS VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039821 ↗
• InjuryJun 13, 2025Use of Incorrect Control/Treatment Settings; Use of Device Problem; Use of Incorrect Control/Treatment Settings; Use of Device Problem

  ON MAY 14, 2025, BREAS RECEIVED A COPY OF A USER FACILITY MDR FROM FDA (#MW5167521) REGARDING AN ALLEGED INCIDENT LEADING TO SERIOUS INJURY(B)(6) INVOLVING A VIVO 45 LS DEVICE ON (B)(6) 2025 AND THE FOLLOWING DESCRIPTION: "A 78 YR. OLD HOSPITALIZED FEMALE PATIENT (PT.) AND FAMILY WERE INFORMED BY HOSPITAL THE PT. WAS WAITING ON ARRIVAL OF BIPAP MACHINE BEFORE ALLOWED DISCHARGE. HOSPITAL'S DURABLE MEDICAL EQUIPMENT (DME) CONTRACTOR ARRIVED WITH A PORTABLE MACHINE THE PT. AND FAMILY ASSUMED WAS THE BIPAP. THE PT. AND FAMILY WERE INSTRUCTED TO BYPASS THE LEAK TEST, FOR THE PT. TO USE THE DME PROVIDERS FITTED MASK AND PARTS ACCOMPANYING THE MACHINE. COPIES OF ORDERS WERE REQUESTED FOR ENSURING INFO ACCURACY. THE PT. WAS TOLD THE DME PROVIDER WOULD BRING COPIES TO THE PT.'S HOME WHEN THE TECH COME TO SET-UP THE MODEM THAT WAS REQUIRED FOR MONITORING COMPLIANCE. ON THE FIRST NIGHT HOME THE MACHINE PRE-USE LEAK TEST DID NOT PASS; FAMILY NOTICED A STICKER ON THE MACHINE INDICATING "PREVENTIVE MAINTENANCE" AS DONE. THE TIME SHOWED APPROXIMATELY 2 MINS BEHIND. FAMILY WAS CONCERNED DUE TO RED FLAGS INDICATED DURING THE DEMONSTRATION AT THE HOSPITAL WHEN THE MACHINE WAS CONNECTED BY THE DEMONS

  Patient problems: Burning Sensation; Dry Mouth; Dyspnea; Polydipsia; Salivary Gland Problem

  MAUDE report 22205125 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "ON OCT 29, 2024 AT 8:13PM, BREAS RECEIVED THE FOLLOWING REQUEST FROM THE HEALTHCARE PROVIDER: DESCRIPTION: PATIENT EXPIRED ON (B)(6) 2024. PER WIFE, SHE FOUND HIM DISCONNECTED. WE ARE WANTING VERIFICATION THAT THE VENT WAS FUNCTIONING PROPERLY. PER DOWNLOAD ALARMS APPEAR TO HAVE FUNCTIONED AS INTENDED. CAREGIVER ATTENDANT: YES. WHEN WAS THE FAILURE FIRST DETECTED?: DURING THE ACTIVE TREATMENT. PATIENT OUTCOME: DEAD. THERE IS NO ALLEGATION AT THIS TIME THAT THE DEVICE HAS MALFUNCTIONED, OR CAUSED OR CONTRIBUTED TO THE EVENT. BREAS RECEIVED THE DEVICE ON NOVEMBER 12TH, 2024 THE INVESTIGATION STARTED ON NOVEMBER 26TH, 2024 AND COMPLETED ON NOVEMBER 26TH, 2024 THE INVESTIGATION INCLUDED THE FOLLOWING ACTIVITIES: ANALYSIS OF LOG FILES. FULL FUNCTIONAL TESTING. INVESTIGATION RESULTS: THE ALARM/EVENTS LOG SHOWS THAT FOR THE ENTIRETY OF THE TREATMENT ON (B)(6), THE DEVICE WAS ALARMING THE HIGH PRIORITY ALARMS "LOW MVE" AND "LOW VTE". REVIEWING THE SETTINGS THAT WERE SET ON THE DEVICE DURING THE TIME OF THE EVENT, WE SEE THE "LOW PRESSURE" ALARM WAS SET TO 6CMH2O AND THE "PEEP" WAS ALSO SET TO 6CMH2O. IN THIS CASE, THE DEVICE KEPT A BASE PRESSURE OF 6CMH2O WHICH PREVENTED THE "DISCONNECTIO

  Patient problems: Insufficient Information

  MAUDE report 20810183 ↗
• InjuryOct 3, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON SEP 5, 2024, BREAS RECEIVED AN INCIDENT REPORT FORWARDED BY THE HEALTHCARE PROVIDER: LOCATION OF INCIDENT: HOME. DESCRIPTION OF INCIDENT: PATIENT WAS ASLEEP AND RESTING WELL WHEN THE VENTILATOR STARTED ALARMING LOW-MINUTE VENTILATION. MOM WENT TO ROOM TO SEE WHAT WAS GOING ON AND NOTICED THAT THE VENT WAS NOT VENTILATING THE PATIENT CORRECTLY. TIDAL VOLUME WAS SET AT 700 AND THE VENTILATOR WAS ONLY GIVING 200-300 CMH2O. THE SECOND VENTILATOR WAS THEN TURNED ON AND DID THE SAME THING. PARENTS WANT THE VENTS REMOVED. HOW WAS THE INCIDENT DETECTED: ALARM AND VISUAL WAS THE PATIENT/CLIENT USING THE EQUIPMENT AT THE TIME: YES. IF YES, DESCRIBE HOW THE EQUIPMENT WAS BEING USED: PATIENT WAS ON VENTILATOR. WAS THE PATIENT/CLIENT INJURED: NO. WAS ANY IMMEDIATE MEDICAL INTERVENTION REQUIRED: YES. IF YES, DESCRIBE THE INTERVENTION PROVIDED: MANUAL BAGGING. WAS THERE ANY DAMAGE TO OTHER PROPERTY OR EQUIPMENT: NO. WAS THE EQUIPMENT REMOVED FROM SERVICE: YES. IF YES, WHERE WAS THE EQUIPMENT SENT: BACK TO THE RENTAL COMPANY TRACE MEDICAL. DESCRIBE ANY IMMEDIATE ACTIONS TAKEN TO SECURE PATIENT SAFETY: PATIENT WAS TRANSFERRED TO A DIFFERENT VENTILATOR. IT WAS LATER ADDED THAT THE EVENT WAS DISCO

  Patient problems: Insufficient Information

  MAUDE report 20360307 ↗
• DeathSep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUGUST 26, 2024, BREAS MEDICAL WAS CONTACTED BY UNIFIED CARE SERVICES TO INSPECT A VIVO 45LS DEVICE, SN (B)(6), WHICH WAS BEING USED BY A PATIENT WHO DIED. THE DEATH OCCURRED ON (B)(6) 2024. NO FURTHER DETAILS WERE PROVIDED ABOUT THE EVEN AFTER MULTIPLE ATTEMPTS TO CONTACT THE INITIAL REPORTER. THERE IS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20250350 ↗
• DeathAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 07/16/2024, BREAS RECEIVED THE FOLLOWING INFORMATION FROM DISTRIBUTOR (B)(4). "PT PASSED ON (B)(6) 2024 POSSIBLY IN LATE AFTERNOON. (B)(4) WASN'T INFORMED UNTIL 7/16 AND RECEIVED MINIMAL DETAILS. THE INCIDENT MAY HAVE HAPPENED WHILE THE PATIENT WAS IN TRANSPORT FROM A PPEC FACILITY THAT WATCHES CHILDREN. A COUSIN OF THE FAMILY WORKS ON A REFERRAL BASIS FOR A PERSONAL INJURY LAW FIRM AND MENTIONED THE SITUATION THE LAW FIRM. THE FAMILY ASKED FOR THE DATA, AND WHEN THEY WERE TOLD THAT (B)(4) WOULD NEED TO DOWN-LOAD THE DATA AND THEN GIVE THEM A COPY, THE ATTORNEYS TOOK POSSESSION OF THE DEVICE. (B)(4) INFORMED THE LAWYERS THAT THE DEVICE IS NOT THEIRS TO TAKE. THE LAWYERS ASKED FOR A PURCHASE OR RENTAL PRICE FOR THE DEVICE SO THAT THEY COULD RETAIN CUSTODY OF THE DEVICE. (B)(4) SUPPLIED THEM WITH A NUMBER THE LAWYERS THEN SAID THAT THEY WILL LOOK FOR "SOMEONE WHO CAN DOWNLOAD THE DATA". (B)(4) INFORMED THEM THAT WAS NOT A GOOD IDEA. THEY INFORMED THEM THAT AN UNQUALIFIED PERSON COULD POTENTIALLY DELETE ALL THE DATA WITH A PUSH OF THE WRONG BUTTON.". IT IS ALLEGED THAT THE PATIENT WAS CONNECTED TO A VIVO 45LS DEVICE, PART NUMBER: 230216 AND SERIAL NUMBER: (B)(6), AT THE TIME OF THE

  Patient problems: Insufficient Information

  MAUDE report 19976204 ↗
• DeathFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON 2 FEBRUARY 2024, BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: I AM EMAILING TO SUBMIT A COMPLAINT RELATED TO POSSIBLE INCIDENT, PLEASE SEE ORIGINAL EMAIL BELOW. I HAVE OPENED UP A CASE IN OUR COMPLAINT HANDLING SYSTEM AND AM AWAITING ADDITIONAL INFORMATION RELATED TO DEVICE DETAILS. MY CASE NUMBER IS BELOW. (B)(4). BIOMED SPECILAIST AT (B)(6) RECEIVED A CALL THIS MORNING FROM PEDIATRIC HOME SERVICE IN (B)(6), APPARENTLY THEY HAD A PATIENT (2 MONTH OLD BABY) DIE THIS MORNING WHO WAS ON ONE OF OUR VENTS. APPARENTLY SHERIFF REACHED OUT TO THE PHS LOCATION WITH THE NEWS. IT SEEMS AS THE VENT WAS SETTING OFF ALL KIND OF ALARMS AND PARENTS DID NOT ACT UPON THEM, NOR WERE THEY GETTING ANY NURSING SERVICES FOR THE BABY. PHS WILL BE SENDING IN THE VENT AND A COMPLETE FULL PM NEEDS TO BE DONE. IT NEEDS TO BE RECORDED ON THE EXACT PERSON WHO OPENS UP THE VENT UPON ITS ARRIVAL THEIR NAME, TIME, AND DATE ARE RECORDED. PHS WILL NEED ALL THE DOCUMENTATION ON THE TECHS FINDING AND PM. WE WILL THEN NEED TO SEND THE VENT BACK TO PHS WHO THEN WILL NEED TO STORE THE VENT UNDER LOCK AND KEY DURING THE INVESTIGATION THIS IS PER THE SHERIFF. I AM WAITING FOR EMAIL FROM MY CONTACT WITH ALL THE DETAI

  Patient problems: Insufficient Information

  MAUDE report 18767983 ↗
• MalfunctionJun 22, 2023Accessory Incompatible; Accessory Incompatible

  BREAS MEDICAL DISTRIBUTOR REPORTED "IN ATTEMPTING TO GIVE NEBULIZER TREATMENT, PATIENT'S O2 SATURATION AND HEART RATE DECREASED DRAMATICALLY" AS COMMUNICATED BY RESPIRATORY THERAPIST. DISTRIBUTOR THEN SPOKE WITH ICU PHYSICIAN WHO CLAIMED SHE WITNESSED THE INCIDENT AND CONFIRMED WHAT THE RESPIRATORY THERAPIST CLAIMED. THE PHYSICIAN SAID HER CONCERN WAS THE VIVO 45 LS STOPPED GIVING A BREATH WHEN NEBULIZER TREATMENT WAS ACTIVATED. NO INJURY WAS CLAIMED. PATIENT IMPACT IS ABSENCE OF TREATMENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17181721 ↗
• MalfunctionMay 5, 2023Unable to Obtain Readings; Unable to Obtain Readings

  CUSTOMER REPORTED THAT THE SPO2 SENSORS WERE WORKING ON WHITE PATIENTS BUT NOT AFRICAN AMERICANS WHEN USED AS AN ACCESSORY TO THE BREAS VIVO 45 LS VENTILATOR. THEY ARE RETURNING THE SENSORS AND CABLES FOR CREDIT AFTER THEY ARE CHECKED OUT BY THE SERVICE TEAM. A TOTAL OF (B)(4) SENSORS WERE RETURNED TO BREAS MEDICAL INC. ON 6 APR 2023. NO DEVICE MALFUNCTION WAS REPORTED FOR THE VIVO 45 LS VENTILATOR. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16874473 ↗
• MalfunctionMar 8, 2023Calibration Problem; Calibration Problem

  PER MDR REPORT (B)(4) AS COMMUNICATED BY THE FDA TO BREAS MEDICAL, INC ON (B)(6)2 022: PT. RECEIVED VIVO 45 AFTER A SOFTWARE UPDATE AND EVERYTHING WAS WORKING AND THEN ONE DAY PATIENT WENT TO GET ON UNIT AND IT RED ERROR AND WOULD NOT ALLOW PATIENT TO USE VENTILATOR. MOBILE MEDICAL WAS NOT ABLE TO GET UNIT TO FUNCTION SO WE GAVE HIM A REPLACEMENT AND SENT UNIT BACK TO MANUFACTURER. THE REPORTER MOBILE MEDICAL WAS CONTACTED TO DETERMINE THE SERIAL NUMBER OF THE DEVICE IN QUESTION, AS WELL AS DETAILS OF THE EVENT. IT TURNED OUT THAT A COMPLAINT TICKET WAS ALREADY OPENED FOR THIS PARTICULAR EVENT AND IS RECORDED IN (B)(4). IT WAS DETERMINED FROM THE COMPLAINT INVESTIGATION THAT THE DEVICE STOPPED DURING DEVICE START UP PROCEDURES, CAUSING AN ALARM TO SOUND, AND SHOWING INTERNAL FUNCTION FAILURE ERROR 2 ON THE SCREEN. IT WAS CONFIRMED THAT THE PATIENT INVOLVED DID NOT SUFFER ANY INJURY OR HEALTH CONSEQUENCES. DEVICE LOG FILES WERE REVIEWED AND IT WAS CONFIRMED THAT THE DEVICE ALARMED WITH INTERNAL FUNCTION FAILURE 2 SEVERAL TIMES. THIS ERROR CODE SIGNALS A FAILURE OF THE MAIN PRESSURE SENSOR DURING STARTUP. THE DEVICE HAS TWO PRESSURE SENSORS, A MAIN AND A BACKUP, WHICH ARE CALIBRATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193586. One submission often covers many models, so check the product and lot details in each record.

• Z-0405-2024 · Oct 13, 2023 · Open, Classified
  with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a pati