Monarch M929241Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10688503241006), received between Oct 21, 2021 and Oct 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Fell” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2021Improper or Incorrect Procedure or Method; Installation-Related Problem; Device Fell

  SAVARIA WAS INFORMED THAT ONE OF THEIR MANUFACTURED CEILING MOUNTED, PATIENT TRANSFER XY SYSTEM (MONARCH) PULLED OUT OF THE CEILING. THE CAREGIVER WAS HIT IN THE HEAD WHEN THE RAIL CAME DOWN BUT DID NOT NEED MEDICAL ATTENTION. THE INVESTIGATION WAS COMPLETED AND THE MANUFACTURER FOUND: THE INSTALLATION WAS DONE BY A TRAINED DEALER (THIRD PARTY) WHO ADMITTED CHANGING THE INSTALLATION METHOD AT THE LAST MINUTE. PICTURES SHOWED THAT THE HARDWARE (LAG BOLTS) THAT WAS USED BY THE INSTALLER (NOT SPECIFIED BY THE MANUFACTURER) PULLED OUT FROM THE HOUSE WOODEN STRUCTURE. DEALER SAID THEY CONDUCTED THE INITIAL WEIGHT LOAD TEST (NOT DOCUMENTED) BUT DID NOT DETECT ANY ANOMALIES AT COMMISSIONING. THE INSTALLATION WAS REDONE PROPERLY AND A WEIGHT TESTED THE DAY AFTER THE EVENT. NO MEDICAL ATTENTION OR EMERGENCY SERVICES WERE REQUIRED AFTER THE INCIDENT.

  Patient problems: Head Injury

  MAUDE report 12675186 ↗