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Model Number HL-390 |
Device Problems
Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Other text: b3: date of event is unknown; no information has been provided to date.D3, g1, and g2 email is: (b)(6).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 showing different numbers rapidly.There was no patient involvement and no patient or clinical injury.
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Manufacturer Narrative
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Device evaluation: one device was received.A visual inspection found the device in good condition but missing the reflux plug.During the functional testing, the customer reported issue was unable to be duplicated.The cause of the issue was likely that the customer had faulty testing equipment.The reflux plug was replaced, along with o rings and the reservoir gasket.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use regulatory.(b)(6).
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Search Alerts/Recalls
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