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Model Number 2110 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: event date unknown.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 information becomes available.
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Event Description
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It was reported that the device exhibited error code 44510.The event was an out-of-box failure and occurred during testing.There was no patient involvement and no patient harm.
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Manufacturer Narrative
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One device was received for evaluation.Visual inspection found a damaged keypad, damaged lens, and a damaged pca connector.There was no applicable evidence in the event history log.Functional testing was able to duplicate the reported problem.It was determined that the faulty pwa board was the root cause and was replaced.The service history review had no indication that the complaint was related to a service of the device within the review period.
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Search Alerts/Recalls
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