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Model Number HL-90 |
Device Problems
Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event and device identification (udi number) 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 display was missing a segment.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Other text: h6: event methods, evaluation, and conclusion codes: updated.One warmer device was received for investigation.During visual inspection the device was observed to have a damaged tank cover and enclosure.Corroded drain fitting and faded line cord.The circuit board and power switch were outdated.The reported issue was confirmed during functional testing when the warmer display was missing lines of pixels.However the investigation could not identify a root cause for the observed condition of the display.As no manufacturing root cause could be identified, no review of manufacturing device history records was conducted.A review of device confirmed this device has not been in for service previously.Due to the age of the device, it has been deemed beyond economical repair and will be decommissioned.
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Search Alerts/Recalls
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