AMC LWM-329DS50/3ARecalls & reported problems

LifeSync Corporation · 3 Lead Disposable DIN to Pinch, Shld, 50", OM Combiner, AHA · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849593017152), received between May 24, 2024 and May 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Defective Device1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMay 24, 2024Defective Device; Defective Device
IT WAS REPORTED BY CUSTOMER THAT : LEAD BROKE APART AT THE PINCH CLIP CONNECTOR WITH ONE HALF COMPLETELY COMING OFF RESULTING WITH BRIEF LOSS OF MONITORING MID MEDICAL PROCEDURE AND SKIN INTEGRITY RISK AS THE BROKEN PIECE WAS LOOKED/FELT FOR UNDER THE PATIENT BUT NOT LOCATED UNTIL POST PROCEDURE WHEN THEY COULD BE MOVED. THIS MEANS A HARD PLASTIC PIECE AND ATTACHED METAL SPRING WAS UNDER THE PATIENT FOR APPROXIMATELY 30 MINUTES. NO INJURY OR ADDITIONAL MEDICAL INTERVENTION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397580 ↗

Device details

UDI-DI	`00849593017152`
Brand	AMC
Model	LWM-329DS50/3A
Company	LifeSync Corporation
Product code	DSA · Cable, Transducer And Electrode, Patient, (Including Connector)
Class	Class 2
FDA submission	K992524
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 15, 2026

Device type (GMDN): Electrocardiographic lead set, single-use

A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.

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All Cable, Transducer And Electrode, Patient, (Including Connector) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.