ook snow FL36 ook snow (REF FL36)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00670482000104), received between Jun 18, 2018 and May 16, 2022 — classified as 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2022Use of Device Problem; Use of Device Problem

  TECHNICAL SERVICE RECEIVED AN EMAIL FROM CUSTOMER REPORTING A PATIENT FALL WITH AN ORBITAL FRACTURE FOLLOWING AN ALLEGED UNDETECTED BED EXITING.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 14406613 ↗
• MalfunctionSep 17, 2021Break; Defective Component; Break; Defective Component

  THE USER ESTABLISHMENT CALLED THE TECHNICAL SERVICE OF MANUFACTURER TO REPORT ABOUT A BED WITH BROKEN BRAKE BAR. HE MENTIONED THAT THE LONG BAR IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490971 ↗
• InjuryNov 8, 2019Device Alarm System

  REPRESENTATIVE OF THE MANUFACTURER WAS CONTACTED BY USER OF A (B)(6) AFTER A PATIENT WAS FOUND, DURING NIGHT WATCH, LYING ON THE GROUND WITH HER PILLOW. IT IS ALLEGED THAT THE BED EXITING DETECTION HAD NOT ALARMED OF PATIENT EXITING. THERE WAS NO INJURY RELATED TO THIS BED EXITING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9298016 ↗
• InjurySep 20, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO THE MANUFACTURER THAT A PATIENT GOT OUT OF BED WITHOUT BEING DETECTED BY THE INTEGRATED DETECTION SYSTEM OF THE MEDICAL BED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100390 ↗
• InjuryJun 20, 2019Use of Device Problem; Use of Device Problem

  MANUFACTURER WAS CONTACTED BY THE USER OF A MEDICAL BED ALLEGING THAT THE INTEGRATED BED EXIT DETECTION SYSTEM WAS NOT OPERATING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. DURING SERVICE VISIT, BED WAS FOUND TO BE OPERATING AND PERFORMING AS EXPECTED AFTER A ZERO WAS MADE.

  Patient problems: No Patient Involvement

  MAUDE report 8718490 ↗
• InjuryMay 24, 2019Use of Device Problem; Use of Device Problem

  MANUFACTURER WAS CONTACTED BY THE MAINTENANCE STAFF OF A USER ESTABLISHMENT ALLEGING THAT A BED EXIT DETECTION SYSTEM WOULD NOT HAVE OPERATED AND, IT RESULTED IN A PATIENT FALL.

  Patient problems: Fall

  MAUDE report 8639794 ↗
• InjuryMay 7, 2019Use of Device Problem; Use of Device Problem

  USER CALLED MANUFACTURER ALLEGING THAT AN INTEGRATED BED EXIT DETECTION SYSTEM REMAINS ARMED AFTER PATIENT EXITED THE BED. NO ADVERSE INCIDENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8588538 ↗
• MalfunctionMar 13, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  USER REPORTED THAT A VISUAL SIGNAL WAS NOT LIGHTING UP WHEN ACTIVATING A BED EXIT DETECTION SYSTEM; IT WAS FOUND THAT THE DETECTION SYSTEM ITSELF WAS NOT OPERATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418536 ↗
• MalfunctionFeb 20, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  MANUFACTURER WAS CONTACTED FOR A MEDICAL BED ALLEGEDLY PRESENTING SENSITIVITY ISSUE WITH THE INTEGRATED BED EXIT DETECTION SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8356062 ↗
• InjuryFeb 4, 2019Calibration Problem; Calibration Problem

  USER PLACED A SERVICE CALL ALLEGING THAT THE BED EXIT DETECTION SYSTEM WAS NOT FUNCTIONING PROPERLY ON ONE SIDE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8302686 ↗
• InjuryJan 11, 2019Use of Device Problem; Use of Device Problem

  SERVICE CALL WAS PLACED WITH THE MANUFACTURER BY USER OF A FL36 MEDICAL BED ALLEGING THAT THE BED EXIT DETECTION SYSTEM SENSITIVITY WAS NOT APPROPRIATE. NO PATIENT ADVERSE EVENT OR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8241619 ↗
• InjuryJan 9, 2019Use of Device Problem; Use of Device Problem

  SERVICE CALL WAS PLACED WITH THE MANUFACTURER BY USER OF A FL36 MEDICAL BED ALLEGING THAT THE BED EXIT DETECTION SYSTEM WAS NOT FUNCTIONING PROPERLY AND RESULTED IN A PATIENT FALL. NO INJURY REPORTED.

  Patient problems: Fall

  MAUDE report 8232508 ↗
• InjuryDec 10, 2018Use of Device Problem; Use of Device Problem

  USER CONTACTED SERVICE SUPPORT FOR AN INTEGRATED BED EXIT DETECTION SYSTEM ALLEGEDLY NOT WORKING PROPERLY. PATIENT "FELT" WITH SCRATCH ON THE SCALP; NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Fall; Head Injury

  MAUDE report 8148109 ↗
• MalfunctionNov 28, 2018Calibration Problem; Calibration Problem

  A SERVICE CALL WAS PLACED BY USER ALLEGING AN ISSUE WITH DETECTION OF PATIENT EXITING THE BED. THERE WAS NO INCIDENT, NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112277 ↗
• MalfunctionNov 20, 2018Use of Device Problem; Use of Device Problem

  WHILE ON SITE FOR A SERVICE CALL, TECHNICIAN WAS INFORMED THAT BED EXIT DETECTION SYSTEM DID NOT DETECTED A PATIENT EXITING THE BED. EVENT DID NOT RESULTED IN A PATIENT FALL OR IN INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8091695 ↗
• MalfunctionNov 14, 2018Calibration Problem; Calibration Problem

  USER REPORTED TO SALES REPRESENTATIVE THAT A BED EXIT SYSTEM ON A MEDICAL BED DETECTS PATIENT EXITING INTERMITTENTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8070746 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT FELT AFTER EXITING HOSPITAL BED. USER ALLEGED THAT DETECTION SYSTEM DID NOT TRIGGER THE PATIENT MOVING OUT OF BED.

  Patient problems: Fall

  MAUDE report 7611311 ↗