HomeSafe AutoAlert Pendant 1840561Recalls & reported problems
Lifeline Systems Company · FD100 AutoAlert Button · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838081383), received between Sep 20, 2018 and Sep 20, 2018 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
- Fall1
- Head Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathSep 20, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUBSCRIBER FELL OUT OF BED. SHE HIT HER HEAD. THE FAMILY REPORTED THE SUBSCRIBER PASSED AWAY AS A RESULT OF HER FALL.
Patient problems: Death; Fall; Head Injury
MAUDE report 7911594 ↗
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- Voalte Nurse Call 4.1Hill-Rom, Inc. · System, communication, powered14 reports
- GEN4 DIRECT ACCESS 4C370U-P10424CCurbell Medical Products, Inc. · System, Communication, Powered3 reports
- GEN4 PLUS, RESPONDER 5, ENHANCED 5C410U-10134003ACurbell Medical Products, Inc. · System, Communication, Powered3 reports
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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