Plant investigation: no parts were returned to the manufacturer for physical evaluation.
Review of the complaint history revealed that the reported event is a known problem.
The reported event was confirmed based on a photo that was provided of the power supply cable.
Most likely, the issue was caused by an electrical connection issue (which could lead to a power outage in the worst-case scenario).
Review of the instructions for use (ifu) was not required because the issue was not user related.
However, a review of the service manual was performed.
This review revealed that part of the technical safety check consists of visually inspecting the aquabplus before use.
A device history record (dhr) review was also performed.
The device was found to be conforming to the specifications for an aquabplus, and was confirmed to be released without any discrepancies.
Review of the repair history was not required.
Since the reported issue is a known problem, reproduction of the failure was not required.
Based on the provided photo, the reported problem was able to be confirmed.
The issue was resolved onsite by replacing the 24v power supply cable.
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A user facility biomedical technician (bmt) reported finding discoloration on the connector of a 24-volt power supply cable from an aquabplus 2000 system.
The connector was described as brownish looking.
Upon further follow-up, it was reported that the discoloration was caused by overheating.
It was suspected that there was a "high voltage spike in the area.
To resolve the reported issue, the cable was replaced.
The sample was not available to be returned for physical evaluation.
A photo of the cable was provided for review.
There was no reported patient involvement associated with the event.
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