Drive LS9500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383257471), received between Jan 6, 2023 and Jan 6, 2023 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryJan 6, 2023Inflation Problem; Inflation Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A LATERAL ROTATION MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER OF THE UNIT REPORTED THAT THE "PUMP IS CONSTANTLY RUNNING AND WILL NOT FILL THE AREA WHERE SHE IS LYING". THE END USER REPORTEDLY NOW HAS 5 BED SORES, WHICH ARE BEING TREATED BY HER HOME HEALTH AIDE. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16112062 ↗