HomeSafe AutoAlert Pendant 300000219851Recalls & reported problems
Lifeline Systems Company · FD100 AutoAlert Button · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838084957), received between Dec 22, 2017 and Apr 13, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Nonstandard Device1
Patient problems
- Fall2
- Bone Fracture(s)1
- Head Injury1
- Hemorrhage/Blood Loss/Bleeding1
- Loss of consciousness1
- Stroke/CVA1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2018Nonstandard Device
THE SUBSCRIBER HAD A FALL DOWN SEVERAL STAIRS. SHE WAS UNCONSCIOUS. SHE WAS BLEEDING FROM THE FALL AND HAD BROKEN SEVERAL BONES.
Patient problems: Bone Fracture(s); Fall; Hemorrhage/Blood Loss/Bleeding; Loss of consciousness
MAUDE report 7429876 ↗InjuryDec 22, 2017Insufficient Device Problem Information
THE SUBSCRIBER FELL AND HIT HER HEAD. IT IS UNCLEAR IF SHE HIT HER HEAD AND THEN HAD A STROKE OR IF THE STROKE CAUSED HER TO FALL AND SHE HIT HER HEAD IN THE PROCESS. THIS HAPPENED IN HER BEDROOM THE NIGHT OF THE (B)(6) OR THE MORNING OF THE (B)(6).
Patient problems: Fall; Head Injury; Stroke/CVA
MAUDE report 7141811 ↗
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- GEN4 DIRECT ACCESS 4C370U-P10424CCurbell Medical Products, Inc. · System, Communication, Powered3 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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