DRIVEMEDICAL K320DFA-ELRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383133904), received between Feb 15, 2021 and Oct 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (2 reports).

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.

• MalfunctionOct 28, 2023Material Fragmentation; Device Unsafe to Use in Environment; Material Fragmentation; Device Unsafe to Use in Environment

  WE RECEIVED THE EMAIL FROM OUR CUSTOMER DRIVE, THE DETAILS AS BELOW: THE MEDICAL DEVICE INVOLVED IN THE INCIDENT IS A WHEELCHAIR, MODEL NUMBER # K320DFA-ELR WITH SERIAL NUMBER # (B)(6). WHILE USING THE DEVICE THE END-USER WAS ROLLING DOWN THE HILL. THE DEVICE HITS A LITTLE BUMP, AND THE SIDE OF THE WHEELCHAIR BY HIS HIPS CRACKED. HE SUSTAINED A SLASH AT THE TOP OF HIS ARM. THE END-USER LIVES IN A REHAB CENTER. DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION TO MEET REPORTING DEADLINES WE WILL FILE A FOLLOW-UP WHEN ADDITIONAL DATA BECOMES AVAILABLE..

  Patient problems: Laceration(s)

  MAUDE report 18026648 ↗
• InjuryFeb 15, 2021Material Fragmentation; Device Unsafe to Use in Environment; Material Fragmentation; Device Unsafe to Use in Environment

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION TO MEET REPORTING DEADLINES WE WILL FILE A FOLLOW-UP WHEN ADDITIONAL DATA BECOMES AVAILABLE.. WHILE USING THE DEVICE THE END-USER WAS ROLLING DOWN THE HILL. THE DEVICE HITS A LITTLE BUMP, AND THE SIDE OF THE WHEELCHAIR BY HIS HIPS CRACKED. HE SUSTAINED A SLASH AT THE TOP OF HIS ARM. THE END-USER LIVES IN A REHAB CENTER.

  Patient problems: Laceration(s)

  MAUDE report 11329753 ↗