SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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Catalog Number 8002950 |
Device Problems
Electrical /Electronic Property Problem (1198); Electrical Shorting (2926)
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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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Event Description
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It was reported that during preventative maintenance testing, it was found that the water pump was not working and blew the fuse immediately after replacement.There was no patient involvement.
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Manufacturer Narrative
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B3: 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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Search Alerts/Recalls
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