Model Number AQUABPLUS 1500 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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Event Description
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A user facility's biomedical technician reported that an aquab plus 1500 had an overheated pin on the 24 volt power supply power cable.The plastic on the pin connection was found to be blackened.The biomed stated they found the damage during machine repair.There was no smoke, burning smell, flame, spark, or arcing noted.There was no other damage to any other components related to the reported events.The biomed provided a picture which showed the blackened pin connection.The damaged wire connection and the 24 volt power supply was replaced and the machine operated properly.The biomed reported that the sample has been returned to the manufacturer.There was no patient involvement associated with the event.
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Manufacturer Narrative
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Additional information: concomitant medical products, device evaluated by mfr: plant investigation: the reported event can be confirmed based on the provided sample.The problem was able to be fixed by replacing the connection wires and the 24 v power supply unit.The failure cause could not be investigated based on the provided machine data, as the operating report are not available prior to the event date and the alarm report does not show any error message.The sd card and the cpu board have been found defective at the day the biomed detected the charred connector at the 24 v dc power supply unit.The device history record related documentation has been reviewed.The device has been found to be conform to the specification and has been released without any discrepancy.No relation to the reported issue could be identified.No separate review of the repair history is required.A replication of this failure type has been found not necessary, as the failure cause could be determined based on the returned sample.The returned connection wires which connects the 24 v power supply unit to the motherboard has been visually examined.The plastics of the 24 v dc connector to the 24 v power supply unit were charred.A more detailed investigation of the 24 v dc female crimp contact shows a dark brown area at contact area and a squeezed contact spring, which is basically responsible for a good connection between male and female contact.In comparison to a new crimp contact, the contact spring dimension of the returned female contact is about 21 % smaller, when the spring contact is released.The charred connector housing and crimp contact at the 24 v reveals an insufficient connection to the power supply unit contributed to an increase of resistance and temperature.The review of the ifu has been found to be not necessary, as the reported issue is not user related.
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Manufacturer Narrative
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Additional information: event.
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Event Description
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Additional information received from the biomedical technician (biomed).The biomed stated that the device was used in a dialysis facility setting.The biomed stated that several days prior to the event there were some ground-fault circuit interrupter (gfci) outlets that tripped; however, the device was not affected.On the day of the event there were no electrical issues in the facility.The device was not affected by any electric issues and was operation.The biomed stated that slow blow glass fuses were used in the power supply box.There were no blown fuses or power issues found.The device was powered up and functioning when the reported event occurred.The biomed confirmed the wire was replaced.The biomed stated that the 24 power board was also replaced, however the device was functioning normally.There were no power issues present so no other parts needed to be replaced.The biomed confirmed the wires were returned to the manufacturer for evaluation.
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Search Alerts/Recalls
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