Alpha Trancell Deluxe ATD001DARRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055982782265), received between Mar 14, 2025 and Mar 14, 2025 — classified as 1 malfunction.

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.

• MalfunctionMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ARJO WAS INFORMED ABOUT THE EVENT INVOLVING THE ALPHA TRANCELL DELUXE MATTRESS. A CUSTOMER REPORTED THAT A PATIENT'S HEAD BECAME TRAPPED BETWEEN AN ARJO MATTRESS AND THE SIDE RAIL OF A NON-ARJO BED. THE PATIENT HAD ALREADY INDICATED SOME PAIN SYMPTOMS, AND SHE WAS PHYSICALLY DETERIORATING. THE PATIENT WAS FOUND AT 3 A.M. O'CLOCK BY THE NIGHT SHIFT. THE PATIENT WAS RESTLESS. THE NIGHT SHIFT PLACED THE PATIENT ON HER BACK. THE PATIENT SUSTAINED NON-SERIOUS INJURIES TO HER FACE, ARM, AND LEG. THE MATTRESS WAS INSPECTED BY AN ARJO TECHNICIAN, AND NO MALFUNCTION WAS FOUND. THE TECHNICIAN STATED THAT THE MATTRESS WAS WELL POSITIONED ON THE MATTRESS BASE, HOWEVER, THE TECHNICIAN NOTED THE SPACE BETWEEN THE MATTRESS AND THE BED SIDE RAIL. THE CUSTOMER REPLACED THE BED AND THE MATTRESS.

  Patient problems: Physical Entrapment

  MAUDE report 21604228 ↗