Model Number 400CE |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2022 |
Event Type
malfunction
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Event Description
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During operation there is a leak in the cold water reservoir.After checking, it was caused by a cracked part in the reservoir.
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Manufacturer Narrative
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Complaint #(b)(4) received.There were no allegations of patient harm.The customer claims during operation, there is a leak in the cold water reservoir.After checking, it was caused by a cracked part in the reservoir.The device was not made available for evaluation.
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Manufacturer Narrative
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Device was received on 4/11/2023 and evaluated on 4/13/2023.The evaluation confirmed the issue; the device was leaking water from the bulkhead fitting at the reservoir.Service replaced the reservoir assembly to correct.
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Search Alerts/Recalls
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