SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-390 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the device fails to recognize the disposable.The product fault occurred during semi-annual testing.The device was being held in storage prior to testing, so there was no patient, or any other staff involved.
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Search Alerts/Recalls
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