SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-390 |
Device Problems
No Audible Alarm (1019); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
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 reservoir gasket is worn out, the main block was loose, and speaker is not alarming.During functional testing the complaint was confirmed.The root cause was a faulty printed circuit board (pcb) and black main block was loose.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 there was no sound when alarming and leaking (black case where you connect the temp it leaks right there).Issue found during testing.There was no patient involvement and no patient harm/adverse event reported.
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Search Alerts/Recalls
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