Holter Software Philips Holter Software (REF 860292)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838094895), received between Nov 3, 2021 and Nov 3, 2021 — classified as 1 death.

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

Recent adverse event reports

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

• DeathNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER INDICATED THERE WAS A PATIENT SAFETY EVENT WHERE THE 7 DAY HOLTER WAS NOT ABLE TO BE PROCESSED IN TIME AND THE PATIENT ENDED UP DECEASED. THE PROCESS TO REVIEW THE 7 DAY RECORDER IS VERY SLOW AND THE SOFTWARE CREATES DELAYS IN REFRESHING WHEN THEY DELETE ARTIFACTS. THEY ARE GETTING ABOUT ~8000 ¿EVENTS¿ TO REVIEW BEFORE THE 7 DAY HOLTER IS PROCESSED. A DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE EVENT. AT THE TIME OF THE EVENT, THE HOLTER SOFTWARE WAS BEING USED TO ANALYZE DATA GENERATED AS THE RESULT OF A 7-DAY STUDY THAT OCCURRED PRIOR TO THE EVENT. THE PATIENT PASSED AWAY PRIOR TO THE CONCLUSION OF THE DATA ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12749393 ↗