Model Number 8401 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that there was blank screen.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Other text: it has been determined that complaint file (b)(4) with a manufacturing report number of 3012307300-2023-02851 is not a reportable complaint.Please disregard the previous submission(s).Any additional reporting will be conducted under the applicable file.
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Manufacturer Narrative
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Evaluation codes: updated.One device was received.Visual inspection noted the battery compartment was damaged.The monitor display is illuminated but no screen information was visible.Tried adjusting screen contrast but this did not help.The customer complaint is confirmed.A device history record (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.Actions taken by the manufacturer; after swapping out the mainboard there was visible screen information on the display image.
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Search Alerts/Recalls
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