LTV 10130 (UDI 00845873000203)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00845873000203), received between Feb 28, 2019 and Jun 20, 2022 — classified as 8 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (32 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2022Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1000 VENTILATOR SHUT OFF WHILE ON PATIENT DURING TRANSPORT, BUT NO HARM ASSOCIATED WITH THE REPORTED EVENT. THE END USERS WERE NOT USING AN EXTERNAL BATTERY PACK AND THE ASSUMPTION IS THE INTERNAL BATTERY DIED. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE UNIT GOT PLUGGED IN AS SOON AS THE USER SAW IT WAS NOT CHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750055 ↗
• MalfunctionMar 1, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1000 VENTILATOR SHUTDOWN WHILE ON A TRANSPORT, BUT INDICATED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13640875 ↗
• MalfunctionMar 1, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED DEVICE SHUT DOWN WHILE ON A TRANSPORT ON THE LAP TOP VENTILATOR 1000. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13640498 ↗
• MalfunctionNov 24, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1000 VENTILATOR WAS HAVING FIO2 INACCURACY. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872662 ↗
• MalfunctionOct 7, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1000 HAS LEAK AT LOWER PORT ON SOLENOID MANIFOLD. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594863 ↗
• MalfunctionJul 20, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR OXYGEN READING WAS 90% WHEN SET AT 100% AND THE TURBINE WAS FOUND TO BE LEAKING. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200230 ↗
• MalfunctionApr 19, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1000 EXPERIENCED DISCONNECT ALARM. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11690619 ↗
• MalfunctionApr 5, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1000 WAS INTERMITTENTLY TURNING ITSELF OFF/ON. THE ISSUE OCCURRED DURING PATIENT-USE AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614434 ↗
• InjuryMar 30, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED DEVICE WAS SHOWING PEAK INSPIRATORY PRESSURE VALUE OF 55 CMH2O AND OXYGEN SATURATION 68-70%, BUT WHEN PATIENT WAS MOVED TO A HAMILTON VENTILATOR PEAK INSPIRATORY PRESSURE CAME AS 35-39 CMH2O AND OXYGEN SATURATION IMPROVED TO 77-81% IN 5 MINUTES ON THE LAP TOP VENTILATOR 1000. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590326 ↗
• InjuryMar 30, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED DEVICE WAS HOOKED ON A PATIENT WHEN EXPIRATORY TIDAL VOLUME AND TIDAL VOLUME READINGS WERE DASHES ON THE LAP TOP VENTILATOR 1000. THE CUSTOMER ALSO REPORTED THAT THE VENTILATOR WAS SWAPPED OUT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590200 ↗
• MalfunctionMar 23, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE THAT THE LAP TOP VENTILATOR 1000 ALARMED LOW PRESSURE . THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555849 ↗
• MalfunctionFeb 11, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE THAT THE LAP TOP VENTILATOR 1200 HAS A TRANSDUCER FAULT. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317940 ↗
• MalfunctionNov 10, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1000 IS ALARMING LOW OXYGEN (O2) PRESSURE WHEN CONNECTED TO 50 PSI WALL O2. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10820272 ↗
• MalfunctionOct 6, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE THAT THE LAP TOP VENTILATOR 1000 PUSHES A VOLUME, BUT WILL NOT DRAW BACK IN ANYTHING OVER 400 MILLILITRES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10639472 ↗
• InjurySep 25, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE DIAL KNOB ON THE LAP TOP VENTILATOR 1000 UNIT WAS NOT ABLE TO CHANGE THE FIO2 (FRACTION OF INSPIRED OXYGEN) HIGHER THAN 50% AND THE KNOB WAS STUCK ON PARAMETERS AFTER CHANGING THE VALUE 1 DIGIT AT A TIME. THE ISSUE OCCURRED DURING PATIENT USE WHILE IN CT (COMPUTED TOMOGRAPHY) EVALUATION WHICH LEADS TO DESATURATION, INCREASED THE PEEP (POSITIVE END-EXPIRATORY PRESSURE) TO +10 AND FIO2 AND KEPT FIO2 AT 50%. THE VENTILATOR WAS TAKEN OUT OF SERVICE WHEN THE PATIENT RETURNED TO THE ICU (INTENSIVE CARE UNIT). THE CUSTOMER CONFIRMED THAT THE PATIENT RECOVERED AND HAD NO LASTING EFFECTS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10588624 ↗
• MalfunctionSep 22, 2020Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1000 IS NOT ALARMING. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10570453 ↗
• InjurySep 17, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE LTV (LAP TOP VENTILATOR) 1000 VENTILATOR SHUT OFF WHILE IN PATIENT USE. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10551461 ↗
• MalfunctionSep 17, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE REVEL VENTILATOR NEEDS SERVICE FOR VENTILATOR INOPERABLE ALARM THAT CANNOT BE TROUBLESHOOTED. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10551457 ↗
• MalfunctionSep 8, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE LAP TAP VENTILATOR 1100 KEEPS ALARMING HIGH PRESSURE AND HIGH PEAK. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 10505323 ↗
• MalfunctionAug 27, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1000 EXPERIENCED INACCURATE VOLUMES. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT.

  Patient problems: No Information

  MAUDE report 10463412 ↗
• MalfunctionAug 18, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED SELECT BUTTON NOT WORKING ISSUE ON THE LAP TOP VENTILATOR 1000. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 10423069 ↗
• MalfunctionAug 14, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE LTV VENTILITAOR IS TURNING ON/OFF BY ITSELF DUE TO A BAD KEYPAD AND MEMBRANE. AT THIS TIME PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10411529 ↗
• MalfunctionAug 2, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT LTV 1000 WAS DELIVERING HIGH PRESSURE. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 10354201 ↗
• MalfunctionAug 2, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE LTV1000 HAS PROBLEM WITH O2 DELIVERY AND IT GIVES LOW O2 PRESSURE ALARM RESULTING IN DECREASED O2 SATURATION ONCE APPLIED. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 10354194 ↗
• MalfunctionJun 29, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT BIOHAZARD FLUID TRAVELED THROUGH THE CIRCUIT INTO INSPIRATORY CONNECTOR OF THE LTV 1000 UNIT AND PARTS REQUIRED REPLACEMENT. AT THIS TIME, PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10210250 ↗