Catalog Number 102956 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No patient involved.The motor is not a single use device.The approximate age of the device is 7 years.The device is expected to return but has not yet returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related wear issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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It was reported that the centrimag motor triggered an m4 alarm when powered up on the lab test console.Upon initial inspection, there was no damage to the cable; however, there was an intermittent short on the motor cable close to the motor body.Because of this, slight movement of the cable by the motor body caused the motor to malfunction.No patient was involved.No additional information was provided.
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Manufacturer Narrative
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The returned motor was evaluated and tested by the manufacturer's technical services representative.Upon arrival the unit was inspected for external damage and few scratches were observed on the motor housing, however these were noted to be cosmetic.Upon connecting the motor to a mock system the device failed during functional testing by triggering an m4 and motor disconnect alarms, and reproducing the reported event.An open or short in the motor cable internal wiring was suspected.The motor couldn't be repaired and was returned to the customer.Due to no longer being suitable for human use, not for human use and defective labels were placed on the motor.It was recommended that the unit be scrapped from customer inventory.Reports of similar events have been documented and corrective action has been initiated to investigate similar issues.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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