Skip to content

NA G.00Recalls & reported problems

Philips Medical Systems Hsg · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838033672), received between Aug 31, 2018 and Aug 31, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

  • Improper or Incorrect Procedure or Method1

Patient problems

  • Overdose1

Recent adverse event reports

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

  • InjuryAug 31, 2018Improper or Incorrect Procedure or Method

    THE CUSTOMER HAS ALLEGED A DRUG "OVERDOSE" EVENT OCCURRED DUE TO A USER DRUG ORDER CONFIGURATION THAT RESULTED IN A OVERDOSE OF PARACETAMOL IV WHERE A 3.5 KG PATIENT WAS PRESCRIBED 45 MG OF PARACETAMOL IV AND THE MAX SHOULD BE 10 MG/KG IV FOR THIS PATIENT. THE DRUG WAS GIVEN. WHILE IT WAS DESCRIBED THAT THE PATIENT WAS NOT HARMED, BASED ON THE PATIENT BEING AN INFANT AND THE INAPPROPRIATE DOSING, CONSERVATIVELY PHILIPS WILL CLASSIFY THIS EVENT AS A SERIOUS INJURY BASED UPON THE LIMITED INITIAL INFORMATION PROVIDED.

    Patient problems: Overdose

    MAUDE report 7837275 ↗

Other DISPLAY, CATHODE-RAY TUBE, MEDICAL devices

All DISPLAY, CATHODE-RAY TUBE, MEDICAL devices →

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