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Catalog Number G02040107-US |
Device Problems
Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585); Arcing (2583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2021 |
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 biomedical technician (biomed) reported that the red/green power button on an aquabplus 2000 had tripped.The aquabplus was in standby mode when this occurred.There were no alarms.After the power button tripped, there was a flash of light that was seen followed by a small amount of smoke and a burning smell.The hood was closed so they were unable to identify the source of the flashing light.The system was immediately unplugged.Upon further inspection, the biomed identified melting and burn damage on many of the cables that connect the motor protection switch to the contactor.One of the cables had burned all the way through to the wire.Three photos were provided for review and this was depicted in one of them.To resolve the reported issue, the biomed replaced the motor protection switch, the damaged cables, and the power contactor.The replaced parts were reportedly returned for manufacturer evaluation.In addition, the ftp machine files were provided to the manufacturer for review.There was no patient involvement associated with the reported event.
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Manufacturer Narrative
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Plant investigation: no indication was made that parts were received for physical evaluation.However, the reported event was confirmed based on the provided pictures and machine files.The failure can be attributed to a contacting problem between the blade receptacles and the contact pins from the motor protection switch, and to random off/on operation of the pumps due to run-dry protection errors.The provided pictures clearly show discolorations on the blade receptacle and wires, which were burnt through to the wire core.During a review of the machine files, no error codes could be identified on the event date.However, prior to the reported event date multiple f-02-50-05 error codes were identified.The random stopping and restarting of the pumps during operation caused by the run dry protection errors attached thermal stress to the correlated power and current carrying parts such as the wiring of the pumps and the motor protection switch.An improper connection of the blade receptacles on the contacts of the motor protection switch can lead to contact resistance.In addition, strong forces attached to the internal wiring on the motor protection switch when lifting the monitor hood can lead to loosened blade receptacles.A review of the device history records (dhr) revealed the device was found to be conforming to the specifications and was released without any discrepancies.An attempt to reproduce the failure is not required as the failure pattern is well known and can clearly be attributed.Review of instruction for use (ifu) and service manual (sm) revealed that the identified error code (f-02-50-05) is adequately addressed.The sm review also revealed that regular visual inspections are adequately addressed.The reported issue was resolved by replacing the motor protection switch, the damaged cables, and the power contactor.The complaint event has been confirmed.
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Event Description
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A user facility biomedical technician (biomed) reported that the red/green power button on an aquabplus 2000 had tripped.The aquabplus was in standby mode when this occurred.There were no alarms.After the power button tripped, there was a flash of light that was seen followed by a small amount of smoke and a burning smell.The hood was closed so they were unable to identify the source of the flashing light.The system was immediately unplugged.Upon further inspection, the biomed identified melting and burn damage on many of the cables that connect the motor protection switch to the contactor.One of the cables had burned all the way through to the wire.Three photos were provided for review and this was depicted in one of them.To resolve the reported issue, the biomed replaced the motor protection switch, the damaged cables, and the power contactor.The replaced parts were reportedly returned for manufacturer evaluation.In addition, the ftp machine files were provided to the manufacturer for review.There was no patient involvement associated with the reported event.
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Search Alerts/Recalls
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