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Pad-Pak for HeartSine samaritan Public Access Defibrillator (PAD)

Product correction and Product alert
Published

What is the problem?

Stryker is conducting a Critical Product Correction of Pad-Paks used with the HeartSine samaritan Public Access Defibrillator (PAD), with an expiry date range between 17 April 2025 to 01 August 2029.

The affected Pad-Paks may not work due to bent locator pins and potential user error from improper insertion of Pad-Paks.

 

Battery and electrode cartridge for HeartSine samaritan PAD PADPAK03

 

Battery and electrode cartridge for HeartSine samaritan PAD PADPAK04

ARTG

Pad-Pak Catalogue Number

Product Description

Pad-Pak Expiry Dates

HeartSine Catalogue Number

HeartSine Product Model

(Your Pad-Pak may be installed in this device)

338960,

312730

PADPAK03

PADPAK04

PADPAK07

Battery and electrode cartridge for HeartSine samaritan PAD

17-April-2025 to

01-August-2029

350BASUK10HeartSine SAM 350P

360BASSJ10

360BASUK10

HeartSine SAM 360P

500BASUK10

500BASUKGW

HeartSine SAM 500P

What are the risks?

If the Pad-Pak locator pins are bent or the Pad-Pak is not properly inserted into the HeartSine samaritan PAD the device may fail to deliver therapy correctly.

This could lead to a delay in treatment or no treatment being delivered during use.

What should I do?

  • Inspect any Pad-Paks to determine if the expiry date is between 17 April 2025 to 1 August 2029.
  • If your Pad-Pak is within the expiry date range remove the Pad-Pak from the HeartSine samaritan PAD and check for bent locator pins (see images below).
  • If locator pins are straight, re-insert the Pad-Pak following the user manual and you can continue to use the HeartSine samaritan PAD.
  • If the locater pins are bent, remove that Pad-Pak from the HeartSine samaritan PAD, set it aside and contact Stryker on 02 8413 1250 or email padpak.ssp@stryker.com to organise replacement Pad-Paks.
  • Once you receive the replacement Pad-Pak/s, please dispose of the affected Pad-Pak/s.
Diagram of HeartSine samaritan Pad-Pak pin location
Image 1: Pin location
Diagram of HeartSine samaritan Pad-Pak bent pin
Image 2: Bent pin
Diagram of HeartSine samaritan Pad-Pak straight pin
Image 3: Straight pin

Further information

Please contact Stryker on 02 8413 1250 or email padpak.ssp@stryker.com for further information.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices . Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS) .

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

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