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LTV 10130JRecalls & reported problems

Carefusion Corporation · ASSY, LTV1000, W/ACCESS, JAPANESE · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845873001750), received between Jun 11, 2020 and Oct 22, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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

Device problems

  • Mechanical Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 22, 2020Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE THAT LAP TOP VENTILATOR 1000 HAS A LOW TIDAL VOLUMES. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10722314 ↗
  • MalfunctionJun 11, 2020Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE ASSY LTV1000 W/ACCESS. (B)(6) VENTILATOR SHUT DOWN ON INTERNAL BATTERY AFTER 10 MINS, THE UNIT DOES NOT TURN ON, THE PIGTAIL IS BROKEN AND THE FI FUSE IS BURNED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 10146034 ↗

Other Ventilator, Continuous, Facility Use devices

All Ventilator, Continuous, Facility Use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.