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Situate 01-0034RRecalls & reported problems

Covidien LP · Delivery Console 200LD-V · Class 1

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 10884521705296), received between Oct 5, 2021 and Oct 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (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.

Most reported problems

Device problems

  • False Positive Result1

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.

  • MalfunctionOct 5, 2021False Positive Result; False Positive Result

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DETECTING ITEMS THAT ARE NOT THERE. THE EXTRA COUNTS THAT WERE EXPERIENCED WAS DUE TO SOME LEFT IN THE BED FRAME. THE UNIT WAS WORKING AS IT SHOULD. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12578526 ↗

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