35 EvolutionRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845699000562), received between Jun 12, 2025 and Jun 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Fell” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Device Fell; Device Fell

  ON 5/13/2025 AGILITI RECEIVED A CALL FROM THE FACILITY STATING THAT THE BED WAS DROPPING DOWN TO LOW POSITION BY ITSELF. ON 6/20/2025 AGILITI RECEIVED FDA LETTER AND MEDSUN FORM 3500A (B)(4) THAT WAS SUBMITTED BY (B)(6) HOSPITAL STATING PATIENT INVOLVEMENT AND THE FOLLOWING. "THE PATIENT WAS UTILIZING A "LOANER" BED WITH AIR MATTRESS CAPABILITIES. THIS REPORTER LOWERED THE BED AFTER PERFORMING PATIENT CARE AND APPROXIMATELY 30 SECONDS AFTER PLACING THE BED IN THE LOWEST POSITION AVAILABLE FOR SAFETY, THE BED DROPPED MAKING A "BOOM" SOUND. THE BED HAD DROPPED TO THE FLOOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312444 ↗
• MalfunctionJun 12, 2025Sparking; Sparking

  CUSTOMER REPORTED POWER CORD ON BEDFRAME WAS SPARKING WHILE IN PATIENT USE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198068 ↗