DRIVEMEDICAL 14026Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383973661), received between Mar 3, 2022 and Mar 3, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2022Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  DRIVE DEVILBISS WAS NOTIFIED ON JANUARY 24, 2022, OF AN INCIDENT WITH A, RENTED, LOWE AIRE PRESSURE MATTRESS THAT WAS PROVIDED ON (B)(6). THIS NOTIFICATION WAS DONE BY THE PATIENT. A SECOND NOTIFICATION FROM THE PATIENT WAS RECEIVED ON JANUARY 31. THE INITIAL NOTIFICATION NOTED THAT THE "MATTRESS IS DEFLATED RIGHT DOWN THE MIDDLE AND SHE IS SUNKEN INTO THE BED." SHE REPORTED THAT SHE "HIT HER CHEEK BONE AND BROKE IT." THE END-USER IS BED BOUND ON A RESPIRATOR AND DOES NOT WANT TO GO TO THE HOSPITAL. SHE HAS A HOME HEALTH CARE NURSE 24 HOURS 7 DAYS A WEEK AND WAS TREATED BY HER AT HOME. IN THE SECOND NOTIFICATION THE END-USER REPORTED THAT SHE HAD DEVELOPED A THIRD DEGREE WOUND DUE TO THE MATTRESS FAILURE. ON JANUARY 28, A NOTIFICATION WAS RECEIVED FROM THE SERVICE PROVIDER. IN THAT NOTIFICATION, THE SERVICE PROVIDER STATES, "I AM CONCERNED THAT POSSIBLY THIS MEMBER ISN'T USING THE CORRECT SETTINGS ON THE BED". ON (B)(6), THE END-USER CONFIRMED THAT HER BED SORES WERE HEALING WITH THE HELP OF HER AT HOME NURSES. WE REQUESTED THE RETURN OF THE UNITS ON (B)(6) FOR EVALUATION. THEY HAVE NOT BEEN RECEIVED AT THE TIME OF THIS FILING.

  Patient problems: Ulcer

  MAUDE report 13660160 ↗