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Catalog Number G02040108-US |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.
The review of the complaint history revealed that the reported event is a known problem.
The reported event can be confirmed by means of the provided photo.
Although machine files were requested for review, the sd card from the system was found to be corrupted.
A records review was performed on the reported serial number.
An investigation of the device manufacturing records was conducted by the manufacturer.
There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.
In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.
Based on the provided photo, the reported problem was able to be confirmed.
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Event Description
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A user facility's biomedical technician (biomed) reported that an aquabplus 2500 system had a motor protection switch failure.
Patient treatments were interrupted for twenty minutes due to the failure.
The machine was put in emergency mode and treatments were resumed.
The machine ran in emergency mode for two days to allow patient treatments to continue.
There were no indications of any adverse events, or patient injuries requiring medical intervention.
After the motor protection switch was replaced, the system was returned to regular mode.
Upon follow-up with the biomed, a photo of the defective motor protection switch was provided.
In the photo, evidence of thermal damage was present on the component.
The sample was not available to be returned for manufacturer evaluation.
Machine files were requested but could not be provided; the system's sd card was found to be corrupted.
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Search Alerts/Recalls
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