SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-390 |
Device Problem
Electrical /Electronic Property Problem (1198)
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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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B3: date of event is unknown; no information has been provided to date.One device was received.Per visual inspection, the water tank cover was cracked on the top.Per functional testing, the device failed the ground bond part of the electrical safety test.The complaint was confirmed.The root cause was a faulty line cord.It was unknown what caused it to become faulty.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.
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Event Description
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It was reported that the device failed the electrical test.Discovered while doing preventative maintenance (pm) testing.There was no patient involvement and no patient harm/adverse event reported.
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Search Alerts/Recalls
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