SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-390 |
Device Problems
Device Alarm System (1012); Defective Alarm (1014)
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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.Device evaluation: one device was received.Per visual inspection, quick connect is corroded, reservoir gasket is worn out, and faded line cord.Per functional testing, the device over temperature alarm is not working.The complaint was confirmed.The root cause was a faulty printed circuit board (pcb).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 over temperature alarm was not working.The event occurred during the 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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