Skip to content

Florence bed FL23SERecalls & reported problems

Umano Medical Inc · AC-powered hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latch able siderails. · Class 2

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00670482000043), received between Jan 25, 2019 and Apr 25, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Split, Cut or Torn3
  • Material Integrity Problem2
  • Break1
  • Mechanical Problem1
  • Unintended System Motion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient2
  • No Patient Involvement2

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2022Material Integrity Problem; Material Integrity Problem

    THE MANUFACTURER WAS INFORMED ON (B)(6) 2022 OF AN ALLEGED REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14196306 ↗
  • MalfunctionApr 25, 2022Material Integrity Problem; Material Integrity Problem

    THE MANUFACTURER WAS INFORMED ON MARCH 29TH, 2022 OF AN ALLEGED REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14196272 ↗
  • MalfunctionDec 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

    THE MANUFACTURER WAS INFORMED ON NOVEMBER 23TH, 2021 OF A BED WITH A DAMAGED POWER CORD. HE MENTIONED THAT THE CORD HAD EXPOSED BARE WIRES. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12972779 ↗
  • MalfunctionSep 21, 2021Break; Break

    THE MANUFACTURER WAS INFORMED ON (B)(6) 2021, OF AN ALLEGED REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12505226 ↗
  • MalfunctionDec 17, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE BED CONTROLS OF A FL23SE HOSPITAL BED WERE NOT WORKING. IT WAS FURTHER OBSERVED THAT THE POWER CORD WAS TORN. THERE WAS NO PATIENT INVOLVEMENT, NO IMPACT OR ADVERSE EVENT.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9482708 ↗
  • MalfunctionDec 16, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE BED CONTROLS OF A FL23SE HOSPITAL BED WERE NOT WORKING. IT WAS FURTHER OBSERVED THAT THE POWER CORD WAS TORN. THERE WAS NO PATIENT INVOLVEMENT, NO IMPACT OR ADVERSE EVENT.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9475443 ↗
  • MalfunctionJan 28, 2019Mechanical Problem; Mechanical Problem

    THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE UNIT HAD REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8283525 ↗
  • MalfunctionJan 25, 2019Unintended System Motion; Unintended System Motion

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS PHANTOM LIFT MOTION. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8279091 ↗

Other Bed, Ac-Powered Adjustable Hospital devices

All Bed, Ac-Powered Adjustable Hospital devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.