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NA SPO2 INFANT SENSORRecalls & reported problems

Philips Medizin Systeme Böblingen GmbH · SPO2 INFANT SENSOR · Class 2

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 00884838010291), received between Jul 16, 2019 and Jul 16, 2019 — classified as 1 malfunction.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Skin Discoloration1

Recent adverse event reports

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

  • MalfunctionJul 16, 2019Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED A SENSOR CAUSED A PATIENT'S FINGER TO BE RED AFTER AN HOUR OF USE. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

    Patient problems: Skin Discoloration

    MAUDE report 8794629 ↗

Other DETECTOR AND ALARM, ARRHYTHMIA devices

All DETECTOR AND ALARM, ARRHYTHMIA devices →

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