Model Number 4000-0105-51 |
Device Problems
Device Alarm System (1012); Alarm Not Visible (1022); Data Problem (3196)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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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 the pump is not able to properly keep the log history.Customer stated that the pump had an audible alarm issue 2 times, but the alarm logs are not showing this error.It was also mentioned that the year of 1980 was displayed in the alarm logs.No patient injury reported.
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Manufacturer Narrative
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No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause for the audible alarms not being logged into the event history log and a date of 1980 being displayed is due to the main board not operating as intended; however, this cannot be confirmed as no product was returned for investigation.The service history review identified an indication that the complaint was related to a service of the device outside of the review period.
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Search Alerts/Recalls
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