Skip to content

CLIMATELINE 36995Recalls & reported problems

Resmed Pty Ltd · CLIMATELINE TUBING · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00619498369959), received between Nov 24, 2021 and Nov 24, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Emits Odor” (1 report).

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

  • Device Emits Odor1

Patient problems

  • Blister1
  • Headache1
  • Nausea1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 24, 2021Device Emits Odor

    BLISTERS IN THROAT, HEADACHE; RESMED SLEEP APNEA CLIMATELINE TUBING REF-36995 MADE IN (B)(4). LOT: 1553562, SN: (B)(4), BRAND NEW TUBING HAS HEAVY CHEMICAL SMELL USED FOR SEVERAL DAYS THINKING IT WOULD STOP. GOT A REPLACEMENT AND IT WAS THE SAME THING. CAN'T USE, IT MAKES ME NAUSEOUS. FDA SAFETY REPORT ID# (B)(4).

    Patient problems: Blister; Headache; Nausea

    MAUDE report 12878185 ↗

Other Ventilator, Non-Continuous (Respirator) devices

All Ventilator, Non-Continuous (Respirator) devices →

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