Pediatric-Pak Pad-Pak-02Recalls & reported problems

Heartsine Technologies Ltd · Battery and Electrode Cartridge · Class 3

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This HEARTSINE Pad-Pak pediatric battery and electrode cartridge supplies power and pads for an automated external defibrillator. Most of the 45 reports describe a bent locator pin on the cartridge, which the reports say can stop the defibrillator from detecting a connected patient or cause it to lose power during use; a few mention power-up, sensing or connection problems. There are no deaths and no injuries. No recalls name this device. Reports rose sharply in the past year, from 5 to 37.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 45
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 05060167120473), received between Sep 8, 2022 and Feb 12, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (40 reports).

7 other recalls cover devices cleared under the same FDA submission (P160008); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Deformation40
Failure to Power Up2
Battery Problem1
Device Sensing Problem1
Loose or Intermittent Connection1

Patient problems

No Clinical Signs, Symptoms or Conditions45

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 12, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322972 ↗
MalfunctionFeb 11, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313176 ↗
MalfunctionFeb 4, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258351 ↗
MalfunctionFeb 3, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254977 ↗
MalfunctionJan 26, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176148 ↗
MalfunctionJan 13, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064405 ↗
MalfunctionJan 13, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24056665 ↗
MalfunctionJan 9, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24017074 ↗
MalfunctionJan 8, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24000822 ↗
MalfunctionJan 6, 2026Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976919 ↗
MalfunctionDec 29, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23914296 ↗
MalfunctionDec 29, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23913024 ↗
MalfunctionDec 29, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23912993 ↗
MalfunctionDec 17, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835341 ↗
MalfunctionDec 17, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835336 ↗
MalfunctionDec 16, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23814440 ↗
MalfunctionDec 10, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767981 ↗
MalfunctionDec 10, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766806 ↗
MalfunctionDec 9, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23755354 ↗
MalfunctionDec 8, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23751297 ↗
MalfunctionDec 8, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23737857 ↗
MalfunctionDec 5, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735110 ↗
MalfunctionDec 5, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735109 ↗
MalfunctionDec 5, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23725100 ↗
MalfunctionDec 5, 2025Material Deformation; Material Deformation
IN RESPONSE TO A PRODUCT FIELD ACTION, THE CUSTOMER CONTACTED HEARTSINE TO REPORT THE PAD-PAK'S LOCATOR PIN IS BENT. THIS ISSUE CAN LEAD TO A FAILURE TO DETECT WHEN A PATIENT IS CONNECTED, OR COULD CAUSE THE DEVICE TO LOSE POWER DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23725099 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160008. One submission often covers many models, so check the product and lot details in each record.

Z-3120-2026 · Jul 27, 2026 · Open, Classified
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P U
Z-3270-2026 · Jul 27, 2026 · Open, Classified
HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (Americ
Z-0288-2026 · Sep 18, 2025 · Open, Classified
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Z-2174-2025 · Jun 30, 2025 · Open, Classified
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD (Public Access Defibrillator)
Z-2143-2023 · Apr 26, 2023 · Open, Classified
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
Z-1217-2023 · Feb 1, 2023 · Open, Classified
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Z-0745-2022 · Jan 13, 2022 · Terminated
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

Device details

UDI-DI	`05060167120473`
Brand	Pediatric-Pak
Model	Pad-Pak-02
Catalog no.	PAD-PAK-02
Company	Heartsine Technologies Ltd
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	P160008
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2023

Device type (GMDN): Non-rechargeable public semi-automated external defibrillation electrode, paediatric

An electrical conductor, with integral batteries and regulated by a dedicated external pulse generator (EPG), designed to create an electrical shock(s) and defibrillate the heart (restore normal rhythm) to treat ventricular fibrillation or pulseless ventricular tachycardia in a pre-pubescent patient. It is a cartridge-type electrode, in pairs, with non-rechargeable batteries that provide the energy to produce the electrical shock(s) after its adhesive pads are placed on the skin of the patient. This is a single-use device that is replaced after a patient application or after elapse of its expiry date.

Other Automated external defibrillators (non-wearable) devices

NA 861290
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NA 861288
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NA 861289
Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)
7 deaths3,385 reports
R SERIES 30001005201310012
Zoll Medical Corporation · Automated external defibrillators (non-wearable)
10 deaths1,720 reports
PHILIPS HeartStart FRx
Philips Electronics North America Corporation · Automated external defibrillators (non-wearable)
26 deaths1,586 reports
LIFEPAK CR2 99512
Physio-Control, Inc. · Automated external defibrillators (non-wearable)
8 deaths1,502 reports
Lifeline Configuration DDU-100A
Defibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)
1 death1,285 reports
PHILIPS HeartStart FR3
Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)
10 deaths1,188 reports

All Automated external defibrillators (non-wearable) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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