HeartStart Medium Switchless Int PdlRecalls & reported problems

Philips Medical Systems Hsg · Medium Switchless Int Pdl · 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 00884838002104), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Deliver Shock/Stimulation1

Patient problems

Unspecified Heart Problem1
Ventricular Fibrillation1

Recent adverse event reports

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

InjuryNov 17, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
IT WAS REPORTED THAT DURING A VENTRICULAR RHYTHM PROBLEM OF THE PATIENT AT THE END OF THE INTERVENTION, THEY NEEDED TO USE THE DEFIBRILLATION PADDLES. AT THE MOMENT OF THE SHOCK, THE DEFIBRILLATOR TURNED OFF AND THE SHOCK WAS NOT ADMINISTERED. THE PADDLES SEEM TO HAVE CREATED AN ELECTRICAL SHORT-CIRCUIT.
Patient problems: Unspecified Heart Problem; Ventricular Fibrillation
MAUDE report 18158924 ↗

Device details

UDI-DI	`00884838002104`
Brand	HeartStart
Model	Medium Switchless Int Pdl
Catalog no.	M1743A
Company	Philips Medical Systems Hsg
Product code	LDD · Dc-Defibrillator, Low-Energy, (Including Paddles)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Nov 24, 2025

Device type (GMDN): Internal defibrillation electrode, adult, reusable

An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop/start the heartbeat during cardiopulmonary surgery. It usually consists of a cable set with spoon-like electrodes (commonly known as internal defibrillator paddles or spoons) that are held by the operator directly to either side of the heart muscle so that the discharge passes directly through the heart. It is typically available as a set of two electrodes with insulated handles with a combined cable/connector. This is a reusable device.

Other Dc-Defibrillator, Low-Energy, (Including Paddles) devices

NA 11131
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1 recall6 reports
NA 11131
Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)
1 recall5 reports
NA 11131
Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)
1 recall1 report
NA 11131
Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)
1 recall0 reports
NA 11131
Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)
1 recall0 reports
NA 11131
Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)
1 recall0 reports
NA 11131
Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)
1 recall0 reports
NA 11131
Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)
1 recall0 reports

All Dc-Defibrillator, Low-Energy, (Including Paddles) devices →

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