Drive 14200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383565866), received between Sep 20, 2024 and Sep 20, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Gas/Air Leak” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 20, 2024Gas/Air Leak; Gas/Air Leak

  (B)(6) 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 MOTHER OF THE END-USER REPORTED THAT THE MATTRESS "HAD BEEN LOW FOR A WHILE" AND HAD NOTICED THIS WHEN ROTATING HIM IN THE BED. THE MOTHER INDICATED THAT THE TUBING HAD DISINTEGRATED WHERE IT ATTACHES TO THE PUMP, AND SHE TRIED TO FIX IT BY USING CLAMPS AND DUCT TAPE. THE MOTHER REPORTED THAT HER SON DEVELOPED A NEW PRESSURE SORE IN THE GROIN AREA THAT IS REQUIRING DEBRIDEMENT. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, (B)(6) HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20273244 ↗