HeartSine Technologies Ltd — Class II: HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067
HeartSine Technologies Ltd has initiated a Class II recall for several SAM series HeartSine samaritan PAD models due to a damaged or over-stretched membrane tail. This mechanical defect causes an intermittent fault in the devices, which are used for victims of cardiac arrest.
This recall affects HeartSine Technologies Ltd, healthcare facilities, and public access points utilizing SAM 350P, 360P, and 450P defibrillators, as well as Quality and Manufacturing departments responsible for component integrity.
The presence of an intermittent fault in a life-sustaining device like an automated external defibrillator (AED) represents a significant reliability concern. For regulatory professionals, this underscores the importance of component-level durability and the potential for assembly-related damage (over-stretching) to trigger post-market enforcement actions. The classification as Class II suggests the FDA views the risk as moderate, yet the nature of the device makes consistent functionality critical.
Quality teams should verify if affected UDI-DI codes are present in their inventory and implement quarantine procedures. Engineering and manufacturing departments should review assembly processes for membrane tails to identify potential stressors that lead to over-stretching. Post-market surveillance teams should monitor for reports of intermittent faults in similar defibrillator models.
Class II. Reason: Due to a damaged (over stretched) membrane tail that causes an intermittent fault.. Product: 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 US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: " Unconscious " Not breathing " Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).. Firm: HeartSine Technologies Ltd (Belfast United Kingdom). Status: Ongoing.
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