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The device history record for the sam 300p device was reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed.
No rework was conducted.
The sam 300p passed ¿out qat from heartsine technologies on the (b)(6) 2007.
Three events were recorded in the devices memory log.
On (b)(6) 2017 06:59:36 the event was 20 minutes 28 seconds in duration.
The pads were initially adhered at 00:01:07.
The patient presented pulseless electrical activity (pea) and there was some high frequency noise in the icg trace.
The device prompted the user to perform chest compressions at 00:01:25, and a ¿pads off¿ prompt was sounded at 00:01:25.
The ¿pads on¿ and ¿pads off¿ prompts continued until the device was switched off.
The patient remained in pea throughout the event, and the high frequency noise in the icg was also visible throughout the event.
On (b)(6) 2017 16:31:36 the event was 9 minutes 37 seconds in duration.
The pads were placed 2 minutes 25 seconds after the pads were placed.
The patient presented asystole and a shock was not advised.
Chest compressions were delivered at an average rate of 192 compressions per minute.
The patient remained asystolic and a shock was not advised.
Chest compressions continued at an average rate of 192 compressions per minute.
The patient remained asystolic and a shock was not advised.
Chest compressions continued at an average rate of 186 compressions per minute until the aed was switched off.
On (b)(4) 2018 16:38:45 the event was 4 minutes in duration.
The device prompted the user to apply the pads throughout.
There is some signal in the ecg trace from 00:00:59 to 00:03:50, but it is unknown if this is cardiac in nature.
The memory log showed that at no time during the reported sca had the device detected an in range patient impedance.
This meant that the device did not progress beyond the advisory speech prompts of apply pads to patient's bare chest as shown in picture.
During the investigation, the device was found to be correctly measuring impedance throughout the range even under the stress of elevated temperature.
The reported fault may have been because of poorly placed electrode pads or an incorrectly installed pad-pak.
This conclusion is further supported by the device performing to specification, when previously attached to a patient on the (b)(6) 2017.
On that occasion, impedances were measured within range throughout the sca and the device successfully entered analysing mode before advising no shock.
This device shall by retained by heartsine as per complaint handling procedure (b)(4).
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