NA C.02Recalls & reported problems
Philips Medical Systems Hsg · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838087965), received between Jun 6, 2024 and Jun 6, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Defective Alarm” (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
Most reported problems
Device problems
- Defective Alarm1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 6, 2024Defective Alarm; Defective Alarm
IT WAS REPORTED THE PATIENT WAS IN PEA (PULSELESS ELECTRICAL ACTIVITY) AND THE ALARM WAS NOT ANSWERED BY THE STAFF. THE CUSTOMER REQUESTED ASSISTANCE IN DETERMINING IF THE ALERT WAS SENT THROUGH CAREEVENT TO THE NURSES' MOBILE PHONES. PER THE NURSE, THERE WERE NO ALARM NOTIFICATIONS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THE PATIENT WAS NOTED TO HAVE DIED.
Patient problems: Insufficient Information
MAUDE report 19476582 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.