AMC LWM-341DS30/5ARecalls & reported problems
LifeSync Corporation · 5 Lead Disposable GE to Pinch, Shld, 30", OM Combiner, AHA · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00849593005982), received between Sep 10, 2024 and Sep 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Communication or Transmission 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.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem1
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.
MalfunctionSep 10, 2024Communication or Transmission Problem; Communication or Transmission Problem
COVENANT HEALTH'S DIRECTOR OF SUPPLY CHAIN AND NURSE MANAGER OF THE PROGRESSIVE CARE CARDIOVASCULAR UNIT REPORTED THAT 5 LEAD DISPOSABLE GE TO PINCH, SHLD, 30", OM COMBINER, AHA PART NUMBER LWM-341DS30/5A, REPORTED FALSELY VFIB/TORSADES MEASUREMENT ON A PATIENT. IT WAS THEN REPORTED THAT THE PATIENT WAS ASLEEP AND NOT IN NEED OF CARDIAC INTERVENTION. IT WAS STATED THAT AFTER THE EVENT AND THE PATIENT WAS DEEMED SAFE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20185872 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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