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Catalog Number 50000000E |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that they wanted to check for some heating issues, the device was very slow to heat from 8c to 40c reaching 20c in 15mins heater was failing.They requested quote for 2000 hour service.System hours were 6237.The device was sent down to them for not reaching temperature.No alerts or alarms reported.They tested the device improperly using a temperature probe taped to the shunt tube.They were instructed to use the service manual and only that procedure to test the device.During power on the device displayed alert 03 (water reservoir low).Advised to drain the device and fill it using the correct procedure.They would call back if they had any issues.Per sample evaluation results received on 02apr2024, it was reported that the ac cca card and power module has degraded due to electrical overstress.Photo shows compressor connector degraded due to electrical stress, causes electrical stress on cca ca card and recommend compressor replacement.I/o circuit card pulled loose from card cage backplane caused chiller pump to not run.
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Search Alerts/Recalls
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