DRIVEMEDICAL 15033Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383180328), received between Aug 16, 2021 and Nov 4, 2022 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Sparking” (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 16, 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.

• MalfunctionNov 4, 2022Sparking; Sparking

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BED MOTOR AND HAND CONTROL BY AN END USER'S DAUGHTER, WHO STATED THAT "HER MOTHER WAS TRYING TO USE THE HAND CONTROL TO MOVE THE BED AND SPARKS STARTED COMING FROM THE MOTOR/WIRE THE HAND CONTROL CONNECTS TO." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THEY UNPLUGGED THE UNIT. NO ONE WAS HARMED AND THE FIRE WAS ONLY ON THE MOTOR/WIRES." THE PRODUCT WAS NEVER RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738334 ↗
• DeathAug 16, 2021Unintended System Motion; Unintended System Motion

  DRIVE DEVILBISS HEALTHCARE IS HE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. THE DEVICE HAS NOT BEEN RETRIEVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS RECEIVED. WHILE IN USE THE INCLINED HEADBOARD SUDDENLY CRASHED DOWN. THE SERVICE PROVIDER REPLACED THE BED AND NOTED THAT THE MOTOR WAS BROKEN. THE USER WAS TRAUMATIZED BY THE SUDDEN MOVEMENT. SHE DID NOT FALL OUT OF THE BED. HER SPOUSE STATED THAT IT REQUIRED TWO DAYS OF HOURLY MEDICATION TO CALM HER DOWN. THE DEATH IS NOT ASCRIBED TO THE INCIDENT AS END-USER WAS ALREADY IN HOSPICE CARE FOR HUNTINGTON'S DISEASE.

  Patient problems: Aspiration/Inhalation

  MAUDE report 12323931 ↗