Vital Signs 2013068-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403252723), received between Nov 15, 2020 and Nov 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unable to Obtain Readings” (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

Recent adverse event reports

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

• MalfunctionNov 15, 2020Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THAT THEY FREQUENTLY LOSE CO2 WAVEFORM ON THEIR NEW GE DASH MONITORING SYSTEM WITH THE VITAL SIGNS¿ ADULT/PEDIATRIC AIRWAY ADAPTER WITH DEHUMIDIFICATION TUBING FOR CAPNOFLEX MODULE. INITIALLY, THEY FELT THE LINES WERE BLOCKED, BUT THE SAME OCCURS EVEN AFTER TRAINING ON PROPER USE/POSITION OF THE LINES. THEY ARE CHANGING THE LINES 3-5 TIMES IN A 12 HOUR SHIFT. THEY ARE UNABLE TO PINPOINT ANY SPECIFIC ACTION THAT CAUSES THE CO2 LINE TO STOP READING. IT DID HAPPEN DURING PATIENT USE WITH NO HARM. THERE WAS AN ACCOMPANYING ALARM, AND THE END USER REPLACED THE CO2 LINE. HOWEVER, THERE IS CONCERN OVER SAFETY TO BOTH PATIENT AND END USER AS CHANGING OF LINES EQUATES TO BREAKING OF THE CIRCUIT (POSSIBLE LOSS OF PEEP) AND EXPOSURE IN A COVID-19 CLIMATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10841487 ↗