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Drive 15970-4280Recalls & reported problems

Drive Devilbiss Healthcare · Pressure PreventionLTC and Hospice Product Description: Gravity 9 Mattress, 42"W x 80"L, 1 EA · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383586519), received between May 2, 2024 and May 2, 2024 — classified as 1 injury.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Emits Odor1

Patient problems

  • Dysphagia/ Odynophagia1

Recent adverse event reports

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

  • InjuryMay 2, 2024Device Emits Odor; Device Emits Odor

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY THE END USER (WHO REPORTED ON MW5153046) WHO REPORTED THAT THE MATTRESS WAS EMITTING AN ODOR CAUSING TIGHT THROAT AND DIFFICULTY SWALLOWING. THE END USER WENT TO AN URGENT CARE FACILITY FOR TREATMENT AND WAS DIAGNOSED WITH DYSPHAGIA AND WAS PRESCRIBED STEROIDS AND ANTIHISTAMINES. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

    Patient problems: Dysphagia/ Odynophagia

    MAUDE report 19234934 ↗

Other MATTRESS, FLOTATION THERAPY, NON-POWERED devices

All MATTRESS, FLOTATION THERAPY, NON-POWERED devices →

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