DRIVEMEDICAL 14530M-MINIRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383932187), received between Sep 28, 2023 and Dec 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Installation-Related 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryDec 19, 2023Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A PRESSURE PREVENTION MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE REPORTER REPORTED THAT THE MATTRESS IS "GOING FLAT," CAUSING THE END USER'S PREEXISTING BED SORES TO BECOME WORSE. THE REPORTER DID NOT PROVIDE ANY OTHER DETAILS OF THE END USER'S PRESSURE INJURY MANAGEMENT PROGRAM, OR ANY INFORMATION REGARDING MEDICAL TREATMENT OF THE EXACERBATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Skin Erosion

  MAUDE report 18358258 ↗
• InjurySep 28, 2023Installation-Related Problem; Installation-Related Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A PRESSURE PREVENTION MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE INITIAL REPORTER INDICATED THAT THE PROVIDER OF THE PRESSURE PREVENTION MATTTRESS DID NOT SET UP THE MATTRESS CORRECTLY AND THE USER DEVELOPED A STAGE 4 PRESSURE ULCER. THERE WAS NO REPORT OF ANY DEVICE DEFECT, OTHER THAN THE IMPROPER SET UP. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. THE PRODUCT IS INVOLVED IN LITIGATION BETWEEN THE INITIAL REPORTER AND THE PROVIDER, AND WILL NOT BE RETURNED.

  Patient problems: Ulcer

  MAUDE report 17840043 ↗