MEDLINE MDT8520TRecalls & reported problems
Medline Industries, Inc. · ALARM,TAMP-RESISTANT,DUAL PADS,EA · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489001648), received between Sep 2, 2026 and Sep 28, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (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. 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
- Battery Problem1
- Defective Alarm1
- Intermittent Continuity1
- Loose or Intermittent Connection1
- Material Twisted/Bent1
- No Audible Alarm1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Skin Tears1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026No Audible Alarm
It was reported that "Alarm not sounding when patients move/ try to get out of bed."
Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Tears
MAUDE report 50913533 ↗MalfunctionSep 23, 2026Defective Alarm; Intermittent Continuity
It was reported that One of the bed alarms was fully connected to the nurse call system; the alarm pad and the battery were full of charge. But it didn't work, no matter if we pressed the side button or reconnect. The other works, but it keeps sending messages to the nurse call system as it is disconnected. There were no reports of death, serious injury, medical intervention, or follow up care. It has been determined that the reported event could cause or contribute to serious injury if it were to occur again. In an abundance of caution, this is a reportable event. If additional information becomes available this report will be reopened and reevaluated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869436 ↗MalfunctionSep 15, 2026Loose or Intermittent Connection; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778376 ↗MalfunctionSep 2, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572763 ↗
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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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