AMC LWM-329DS50/5ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849593016391), received between Aug 24, 2022 and Aug 22, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023

  CVOR (CARDIOVASCULAR OPERATING ROOM): DURING PROCEDURE, AMC 5 LEAD CABLES WERE DIFFICULT TO ATTACH. CONNECTION WAS TIGHT INTO THE MAIN ECG CABLE. ECG WORKED FOR A SHORT TIME, THEN THE V LEAD DID NOT WORK. IT WOULD RETURN INTERMITTENTLY. ANOTHER CABLE USED WITHOUT FURTHER PROBLEMS. NO KNOWN HARM TO PATIENT, MINOR DELAY IN PROCEDURE. SAME DEVICE REPORTED YESTERDAY FOR THE SAME REASON. BOTH HAD THE SAME LOT #. MANUFACTURER RESPONSE FOR CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR), AMC (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595024 ↗
• MalfunctionAug 17, 2023

  CVOR (CARDIOVASCULAR OPERATING ROOM): DURING PROCEDURE, AMD 5 LEAD CABLES WERE DIFFICULT TO ATTACH. CONNECTION WAS TIGHT INTO THE MAIN ECG CABLE. ECG WORKED FOR A SHORT TIME, THEN THE V LEAD DID NOT WORK. IT WOULD RETURN INTERMITTENTLY. ANOTHER CABLE USED WITHOUT FURTHER PROBLEMS. NO KNOWN HARM TO PATIENT, MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR), AMC (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563169 ↗
• MalfunctionAug 24, 2022Device Sensing Problem

  DURING PROCEDURE IN CARDIOVASCULAR OPERATING ROOM (CVOR), THE AMC 5 LEAD DISPOSABLE WAS USED. THE ONLY LEAD THAT GAVE A SIGNAL WAS III. THIS WAS ATTEMPTED 2 MORE TIMES, WITH 2 MORE DEVICES, WITH THE SAME RESULTS (ALL 3 DEVICES HAD THE SAME LOT NUMBER). MANUFACTURER RESPONSE FOR CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR), AMC (PER SITE REPORTER): WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282367 ↗