McKesson Cardiology ECG Management 13.2.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 80010939040011), received between Aug 12, 2020 and Aug 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A PHYSICIAN REPORTED THAT THE ONCOLOGY MEDICAL STAFF DELAYED A MEDICATION ADMINISTRATION TO A PEDIATRIC PATIENT DUE TO PROLONGED AUTOMATED QTC VALUES THAT WERE PRESENTED IN A REPORT CREATED BY THE MCKESSON ECG MANAGEMENT SYSTEM. THE REPORTING PHYSICIAN FURTHER CLAIMS THAT FOLLOWING HIS CONSULTATION THE PATIENT EVENTUALLY RECEIVED THE MEDICATION AND IS NOW RECEIVING APPROPRIATE CARE.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10398464 ↗