Model Number HL-90 |
Device Problems
Display or Visual Feedback Problem (1184); Output Problem (3005); Temperature Problem (3022)
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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.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 during testing the liquid crystal display (lcd) and the temperature on the unit were unable to be adjusted.
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Manufacturer Narrative
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H3 and h6 - updated one device was received for investigation.The device was visually inspected and functionally tested.The reported complaint was confirmed as we were not able to adjust the lcd, due to the pot on the pcb was loose.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped.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.
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Search Alerts/Recalls
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