Medline MDT8450YRecalls & reported problems
Medline Industries, Inc. · ALARM,TAMP RES,NURSE CALL,EA · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888277675209), received between Dec 4, 2024 and Sep 29, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (10 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- No Audible Alarm10
- Electrical /Electronic Property Problem7
- Defective Alarm4
- Failure to Power Up2
- Smoking2
- Battery Problem1
- Device Alarm System1
- False Alarm1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Bruise/Contusion1
- Dementia1
- Fall1
- Hematoma1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932936 ↗MalfunctionSep 28, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924366 ↗MalfunctionSep 24, 2026No Audible Alarm; Battery Problem
It was reported that "Alarm did not work."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883109 ↗MalfunctionSep 21, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845975 ↗MalfunctionSep 17, 2026Fire
It was reported that ALARM CAUGHT ON FIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803128 ↗MalfunctionSep 15, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777534 ↗MalfunctionSep 10, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717258 ↗MalfunctionSep 10, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716750 ↗MalfunctionSep 10, 2026No Audible Alarm; Electrical /Electronic Property Problem
It was reported that "The unit won't audibly alarm though" and "one of the soldering joints was disconnected."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714026 ↗MalfunctionSep 7, 2026False Alarm; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655785 ↗MalfunctionSep 4, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50620677 ↗MalfunctionSep 4, 2026No Audible Alarm
It was reported that "ON 1/24 THE ALARM STOPPED RESPONDING" and "One evening it just stopped arming when weight was on the pad. No beep to register arming and no alarm when off of pad. Pad worked in another device no problem."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619436 ↗MalfunctionSep 3, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595854 ↗MalfunctionSep 2, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573089 ↗MalfunctionSep 2, 2026No Audible Alarm
Patient problems: Dementia
MAUDE report 50572587 ↗MalfunctionSep 2, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563611 ↗MalfunctionSep 1, 2026No Audible Alarm; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545599 ↗MalfunctionJul 8, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25748321 ↗MalfunctionJun 23, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE PRODUCT WAS CONTINUOUSLY ALARMING, STAFF WAS UNABLE TO RESET IT DUE TO A BUTTON ON THE SIDE BEING STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25596039 ↗MalfunctionJun 19, 2026Defective Alarm
CUSTOMER STATED "THE CHAIR ALARM IS NOT SOUNDING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25568511 ↗MalfunctionJun 1, 2026Defective Alarm
IT WAS REPORTED THAT THE BED ALARMS ARE NOT FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351649 ↗MalfunctionMay 29, 2026Defective Alarm
IT WAS REPORTED THAT THE ALARMS ARE NO LONGER WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25336986 ↗MalfunctionMay 28, 2026Defective Alarm
IT WAS REPORTED THAT THE PRODUCT WAS "CONTINUOUSLY ALARMING, AND STAFF WAS UNABLE TO RESET".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25320389 ↗MalfunctionMay 26, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE ALARM "DOES NOT WORK".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25289823 ↗MalfunctionMay 18, 2026No Audible Alarm; Premature Discharge of Battery; Temperature Problem
IT WAS REPORTED THAT THE PATIENT'S MOTHER HAD FALLEN OUT OF BED DUE TO THE BED ALARM NOT FUNCTIONING RESULTING IN BRUISING TO HER BACK AND A HEMATOMA TO THE SIDE OF HER HIP. THE CUSTOMER REPORTED THAT NO MEDICAL INTERVENTION WAS NEEDED. THE CUSTOMER ADDITIONALLY STATED THAT THE "BATTERY WAS HOT TO THE TOUCH" AND "WOULD RUN OUT OF ENERGY QUICKLY."
Patient problems: Bruise/Contusion; Fall; Hematoma
MAUDE report 25205812 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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