Vital Sync VITALSYNCSW03 (UDI 10884521844933)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521844933), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 30, 2026Open, Classified

   Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

   Z-1557-2026 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionMar 7, 2024Computer Software Problem; Computer Software Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE REMOTE SURVEILLANCE SYSTEM HAD NO ANY AUDIBLE ALARMS ON THE CNS. TROUBLESHOOTING WAS REMOTED INTO, LOOKED AT THE TILES FOR ROOMS. IT WAS COLOR RED AND ORANGE BUT THERE WAS NO AUDIBLE ALERT. CLICKED ON THE TILE AND SEE THAT THE ALARM WAS SILENCED. THE RESOLUTION WAS TO UPDATE THE OPERATING SYSTEM TO CORRECT THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862687 ↗