DRIVEMEDICAL CX420ADDA-SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383528366), received between Oct 9, 2020 and Oct 28, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2023Material Separation; Material Separation

  WE RECEIVED THE EMAIL FROM OUR CUSTOMER DRIVE, THE DETAILS AS BELOW: NOTIFICATION OF DRIVE MDR REPORT TO FDA - ITEM # CX420ADDA-SF - JIANGSU JUMAO X CARE MEDICAL EQUIPMENT - TICKET # 257017 - 2438477-2020-00048. THE MEDICAL DEVICE INVOLVED IN THE INCIDENT IS A WHEELCHAIR, ITEM # CX420ADDA-SF WITH A SERIAL NUMBER (B)(6). DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. DRIVE HAS NOT RECEIVED THE UNIT BACK FOR EVALUATION. IF WE RECEIVE THE UNIT BACK WE WILL FILE A FOLLOW-UP SUBMISSION. THE WHEELCHAIR WAS IN USE WHEN A BOLT CAME LOOSE FROM ITS NUT. THE WHEEL CAME LOSE. THE END-USER FELL. IT IS REPORTED THAT THE END-USER SUSTAINED SERIOUS AND PERMANENT INJURIES "INCLUDING, BUT NOT LIMITED TO, BRAIN TRAUMA RESULTING IN MULTIPLE SEIZURES AND BRAIN SURGERY."

  Patient problems: Brain Injury

  MAUDE report 18026613 ↗
• InjuryFeb 13, 2023Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY PROVIDER WHO STATED THAT "THE WHEEL BROKE OFF AND THE END USER FELL IN THE UNIT," AND WAS REPORTEDLY TAKEN TO THE HOSPITAL BY AMBULANCE WHERE HE WAS ADMITTED. 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: Fall

  MAUDE report 16364039 ↗
• InjuryOct 9, 2020Material Separation; Material Separation

  (B)(6) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A WHEELCHAIR. (B)(6) HAS NOT RECEIVED THE UNIT BACK FOR EVALUATION. IF WE RECEIVE THE UNIT BACK WE WILL FILE A FOLLOW-UP SUBMISSION. THE WHEELCHAIR WAS IN USE WHEN A BOLT CAME LOOSE FROM ITS NUT. THE WHEEL CAME LOSE. THE END-USER FELL. IT IS REPORTED THAT THE END-USER SUSTAINED SERIOUS AND PERMANENT INJURIES "INCLUDING, BUT NOT LIMITED TO, BRAIN TRAUMA RESULTING IN MULTIPLE SEIZURES AND BRAIN SURGERY."

  Patient problems: Brain Injury

  MAUDE report 10659813 ↗