Dolphin Fluid Immersion Simulation DLPH-3582NCOOJ-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857268006738), received between Oct 21, 2024 and Jan 24, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• MalfunctionJan 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER AGILITI, ACCORDING TO THE SUPERVISOR AT (B)(6) HOSPITAL IN MIAMI, PATIENT FELL OFF BEDFRAME. ALL FOUR SIDERAILS WERE UP, ALARM WAS ON AND ALERTED THE FLOOR WHEN THE PATIENT FELL. PATIENT WAS ON JOERNS MANUFACTURED DOLPHIN FIS MATTRESS AND CONTROL UNIT. AGILITI WILL PERFORM TESTING. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.

  Patient problems: Fall

  MAUDE report 21229858 ↗
• InjuryJan 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER (B)(6), RECEIVED A CALL FROM CONTACT AT (B)(6), THAT A PATIENT HAD A FALL THAT INVOLVED A BED RENTAL. PER STAFF, THE PATIENT FELL OUT OF THE BED. BED EXIT ALARM DID NOT ALARM. PATIENT WAS TREATED AND STABILIZED. THEY PLACED THE PATIENT BACK INTO THE BED AT THAT TIME THE BED EXIR ALARM WAS ACTIVATED AND WOULD NOT DEACTIVATE. JOERNS IS NOT THE MANUFACTURER OF THE BED FRAME THAT THE PATIENT WAS ON BUT IS THE MANUFACTURER OF THE MATTRESS AND CONTROL UNIT THAT WAS USED ON TOP OF THE BED FRAME. JOERNS IS REQUESTING THE MATTRESS AND CONTROL UNIT BACK FOR INVESTIGATION. COMPLAINT # (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE PRODUCTS RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE PRODUCTS HAVE NOT BEEN RETURNED.

  Patient problems: Fall

  MAUDE report 21175771 ↗
• InjuryOct 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER AGILITI - PATIENT FELL OFF AGILITI EQUIPMENT. THE UNIT REPORTED THAT THE MATTRESS AND RAILS WERE AT THE SAME LEVEL AT THE TIME IT WAS BEING USED BY THE PATIENT. AGILITI EMPLOYEE MET WITH THE FLOOR MANAGER MAND THE FLOOR EDUCATOR TO EVALUATE THE PRODUCTS. AGILITI WILL BE PERFORMING TESTING ON THE EQUIPMENT. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.

  Patient problems: Fall

  MAUDE report 20500770 ↗