Vivo 50 USRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07321822150005), received between Oct 21, 2015 and Jul 1, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (2 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ALARM SOUNDED AND AN INTERNAL FUNCTION FAILURE 34 WAS DISPLAYED. SHORTLY AFTER THE VENTILATOR FAILED. THIS HAPPENED ON (B)(6) 2022. THE PATIENT INVOLVED WAS NOT INJURED DURING THE INCIDENT. INVESTIGATION: THE DEVICE WAS SENT TO BREAS MEDICAL GMBH AND ARRIVED 28TH OF JUNE 2022. ON THE NEXT DAY, BREAS MEDICAL GMBH STARTED THE EXAMINATION OF THE DEVICE. GENERAL INSPECTION SHOWED THAT THE DEVICE IS IN GOOD SHAPE. IT WAS RUNNING FOR 11745 OP. HOURS AND HAS FIRMWARE 2.16 LOADED. THE DEVICE WAS STARTED, A PRE-USE TEST WAS CARRIED OUT SUCCESSFULLY AND A TEST RUN WAS DONE ON A TEST LUNG USING THE PATIENT´S SETTINGS. THE POWER FAIL ALARM WAS CHECKED, IT WORKED AS INTENDED AND THE DEVICE GAVE AUDIBLE, WITH LEVEL FOR 85DB ±5DB THAT CANNOT BE CHANGED OR TURNED OFF, AND VISIBLE ALARMS. THE LOG FILES WERE DOWNLOADED AND EXAMINED WITH THE PC SOFTWARE VERSION 3.3.1.4. THE LOG FILES COULD ESTABLISH THAT TREATMENT WAS STARTED ON 14TH, JUNE 2022 ON MAINS POWER AT 12:51:19. ONE HOUR AND 12 MINUTES LATER C AT 14:03:03. THE DEVICE WAS RESTARTED BY DIS- AND RECONNECTING MAINS POWER AND STARTING TREATMENT AT 14:11:49. ERROR 34 REOCCURRED IMMEDIATELY AND PREVENTED A RESTART OF THE THERAPY. AT 14:17:58 A RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883108 ↗
• MalfunctionSep 6, 2021Defective Device

  THE LOG FILES COULD ESTABLISH THAT TREATMENT WAS STARTED ON (B)(6) 2021, AT 09:25:27 ON MAINS. SEVERAL "HIGH-VOLUME" ALARMS TOGETHER WITH "DISCONNECTION" ALARMS OCCURRED DURING THE FOLLOWING 3 DAYS AND NIGHTS WHEN SUDDENLY FUNCTION FAILURE 39 OCCURRED ON (B)(6) 2021 AT 23:04:23 AND TERMINATED ACTIVE TREATMENT WITH HIGH PRIORITY AUDIBLE AND VISUAL ALARM. THE SUBSEQUENT ALARMS ERROR 43 OCCURRED AS A RESULT OF THE PSU FAILURE WHICH CAUSED ERROR 39. THE PATIENT INVOLVED WAS NOT INJURED DURING THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12428312 ↗
• MalfunctionMar 30, 2021Break

  FAULT DESCRIPTION PER THE REPORTER "ACCORDING TO THE NURSE THERE WAS A LOUD BANG THIS MORNING AND AFTERWARDS THE DEVICE GAVE SEVERAL ERROR CODES (18,39 AND 43). CASE IS BROKEN AT SOME BUSHINGS". THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590045 ↗
• MalfunctionMar 18, 2021Failure to Run on Battery

  PER THE REPORTER: THE TREATMENT WAS TERMINATED WHEN RUNNING ON THE INTERNAL BATTERY. IT HAS BEEN CONFIRMED THAT THERE WAS NO PATIENT INJURED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11511259 ↗
• MalfunctionJan 25, 2017Device Operational Issue; Maintenance Does Not Comply To Manufacturers Recommendations; Device Operational Issue; Maintenance Does Not Comply To Manufacturers Recommendations

  THE UNIT IS 3,5 MONTHS OLD. DURING THE NIGHT THE VENT STOPPED DELIVERING PRESSURE AND SHUT DOWN AT APPROXIMATELY 1:56 AM, WHILE IT WAS CONNECTED TO MAIN POWER SUPPLY. IT DIDN'T SWITCH TO INTERNAL BATTERY. BASED ON OUR REVIEW OF THE DEVICE LOGS, THE DEVICE APPEARS TO HAVE SOUNDED AN ALARM WHEN THE ERROR OCCURRED IN ACCORDANCE WITH THE DEVICE'S SPECIFICATIONS, BUT BREAS MEDICAL (B)(4) IS AWAITING A RETURN OF THE DEVICE TO CONFIRM THAT THE ALARMS ARE OPERATING PROPERLY. THE PATIENT'S MOTHER AWOKE AT APPROXIMATELY 2:00 AM TO CHECK ON HER CHILD AND SAW THE CHILD WAS WITHOUT OXYGEN AND BECOMING BLUE AND THE VIVO WAS NOT OPERATING. SHE IMMEDIATELY STARTED THE VENT AND HAS SAID THE UNIT WAS THEN OPERATING FINE AND CHILD STARTED TO BREATHE AGAIN. THE DEVICE LOG INDICATES THAT THE DEVICE WAS RESTARTED AT APPROXIMATELY 1:59 AM. THE CHILD IS PRESENTLY IN THE HOSPITAL AND IN STABLE CONDITION, BUT WE DON'T HAVE ANY OTHER INFORMATION ABOUT THE STATUS OF THE CHILD.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6275488 ↗
• Nov 18, 2016Device Operational Issue; Device Operational Issue

  HEALTHCARE FACILITY IN THE (B)(6) REPORTS A PROBLEM ENCOUNTERED WITH A BREAS VIVO 50 VENTILATOR DURING TREATMENT. PER THE INITIAL REPORTER: "THE VENTILATOR WAS DISCOVERED TO HAVE TURNED OFF FOR A PERIOD OF 38 MINUTES. STAFF HAD TO PHYSICALLY TURN THE MACHINE BACK ON. THE RESIDENT DID NOT COME TO HARM. VENTILATOR TAKEN OUT OF USE AND ENGINEER CONTACTED TO CHECK THE MACHINE. THIS WAS TAKEN AWAY BY DEVA MEDICAL AND CHECKED. THEY COMPLETED ALL CHECKS AND THEY COULD FIND NO FAULT WITH THE MACHINE. THE HISTORY DISPLAY SHOWS THAT TREATMENT WAS STOPPED AT 18.16 AND THEN RESTARTED AT 18.59. A FULL INVESTIGATION HAS TAKEN PLACE AND THE OUTCOME WAS THAT THE MACHINE HAS AN INTERMITTENT FAULT, AS IT HAD DONE THIS AT LEAST ONCE BEFORE. A DELIBERATE ACT OF TURNING OFF THE VENTILATOR HAS BEEN RULED OUT." THE REPORTER CLAIMS THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT, BUT IF THE SITUATION WERE TO RECUR, IT MIGHT POTENTIALLY RESULT IN SERIOUS INJURY. AT THIS POINT, THE INITIAL REPORTER ALSO CONCLUDED "INTERMITTENT FAULT COULD NOT BE RULED OUT, NEITHER COULD HUMAN INTERVENTION" AFTER THEIR CONTRACTED SERVICE PARTNER DEVA COULD NOT FIND ANYTHING WRONG WITH THE DEVICE - THE DEVICE PA

  Patient problems: Low Oxygen Saturation

  MAUDE report 6112205 ↗
• Oct 24, 2016Delayed Alarm; Improper Alarm; Delayed Alarm; Improper Alarm

  HOSPITAL IN (B)(6) REPORTS A PROBLEM ENCOUNTERED WITH A VIVO 50 VENTILATOR IN A HOMECARE ENVIRONMENT, STATING: "THE ALARM FOR [PATIENT] DISCONNECTION DOES NOT ALWAYS TRIGGER AS EXPECTED. DURING TESTING, A 40-SECOND DELAY HAS BEEN OBSERVED" [TRANSLATED FROM (B)(6)]. THE REPORTER CLAIMS THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT, BUT IF THE SITUATION WERE TO RECUR, IT MIGHT POTENTIALLY RESULT IN SERIOUS INJURY, IF PHYSIOLOGICAL ALARM SETTINGS ARE NOT PROPERLY USED. BASED ON THE INFORMATION PROVIDED AT THIS TIME, INDICATING A USE ERROR, THE REPORTED EVENT IS CONSIDERED REPORTABLE PER 21 CFR PART 803.3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6050427 ↗
• MalfunctionOct 21, 2015Fail-Safe Design Failure; No Flow

  DUSTRIBUTOR IN (B)(6) REPORTED A VIVO 60 VENTILATOR STOPPED TREATMENT WITHOUT GIVING ALARM. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT, AS CARE GIVER WAS PRESENT NEXT TO THE PATIENT. THE VIVO 60 IS NOT MARKETED IN THE USA, BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A SIMILAR MODEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5165105 ↗