SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-90 |
Device Problems
Device Alarm System (1012); Fracture (1260); Insufficient Heating (1287)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date of event and d5.Operator of device 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 has a crack in the main body.Error alarm sound doesn't stop.Water doesn't warm.There was no patient involvement and no patient harm/adverse event reported.
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Manufacturer Narrative
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One warmer device was received for investigation.During visual inspection, cracks were observed on the cover of the circulating water tank.The reported issue was confirmed during functional testing when the device temperature display was inaccurate and then overt temperature alarm was activated.The investigation traced the issue to the device circuit board, which was determined to be damaged.The investigation attributed the root cause of this condition to a physical impact.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.Per the customer's request, no repairs were performed on the device, and it was returned to the customer.
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Search Alerts/Recalls
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