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DeVilbiss DV5MRecalls & reported problems

Devilbiss Healthcare LLC · Smartlink System · 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 00885304006862), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (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

  • Thermal Decomposition of Device1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionFeb 2, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

    AS INDICATED IN AN EMAIL COMMUNICATION FROM (B)(4) (DEVILBISS HEALTHCARE'S (B)(4) DISTRIBUTOR), A CUSTOMER RETURNED A DEVILBISS MANUFACTURED CPAP PRODUCT: "CPAP INTELLIPAP, MODEL DV53" ASSERTING THE DEVICE HAD "BURNED." UPON OUR REQUEST, THE DISTRIBUTOR PROVIDED PHOTOGRAPHS OF THE DEVICE, WHICH INDICATED THE LOCATION OF THE BURNED AREA, WHICH APPEARED TO BE AT THE AC POWER SUPPLY INPUT. THE DISTRIBUTOR ((B)(4)) ALSO STATED THERE WAS NO REPORT OF INJURY ASSOCIATED WITH THIS INCIDENT.

    Patient problems: No Information

    MAUDE report 7237577 ↗

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.