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NA 11110Recalls & reported problems

Physio-Control, Inc. · CABLE ASSEMBLY, 3-LEAD ECG, IEC, ROHS · 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 00883873832622), received between Jun 22, 2022 and Jun 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Temperature Problem” (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

  • Temperature Problem1

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.

  • MalfunctionJun 22, 2022Temperature Problem; Temperature Problem

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE 3 LEAD-ELECTRODES OF THEIR LIFEPAK 20 DEVICE HAD BURNED THE SKIN OF THE PATIENT. IT WAS REPORTED THAT THE PATIENT DID SUSTAIN SKIN BURNS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE, HOWEVER THE HEALTH CARE PROVIDER INVOLVED STATED THAT THEY DO NOT BELIEVE THE DEVICE USE CONTRIBUTED TO THE PATIENT OUTCOME.

    Patient problems: Insufficient Information

    MAUDE report 14777449 ↗

Other CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices

All CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices →

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