Smart Cable NMT Module and Accessories AF-201PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04931921011072), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Alarm Not Visible” (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.

• MalfunctionMar 6, 2024No Audible Alarm; Alarm Not Visible; Protective Measures Problem; No Audible Alarm; Alarm Not Visible; Protective Measures Problem

  NIHON KOHDEN CLINICAL APPLICATION SPECIALIST (NKCAS) WAS ON-SITE WHEN THE ISSUE OCCURRED THAT THE G9 MONITOR DID NOT ALARM FOR THE TOF ALARM (TRAIN OF FOUR) WHEN USING THIS NMT SMART POD, TOF DEVICE WITH A G9 BEDSIDE MONITOR (BSM) DURING A SURGICAL PROCEDURE. NK CAS CONFIRMED THE NMT SMART POD'S VALUE REACHED THE ALARM LEVEL LIMIT VALUE, BUT NO ALARM WAS TRIGGERED EVEN IN ALARM EVENTS. NO PATIENT HARM WAS REPORTED. NK CAS COPIED ALL CLINICAL SETTINGS FROM A KNOWN WORKING NMT SMART POD, TOF DEVICE BUT THE ISSUE PERSISTED. NK CAS CONCLUDED THAT IT WAS NOT THE G9 BEDSIDE MONITOR (BSM) THAT HAD THE ISSUE, IT WAS AN ISSUE WITH THE NMT SMART POD, TOF AND FURTHER INVESTIGATION IS ON-GOING BY NK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847703 ↗