Model Number 2120 |
Device Problems
Mechanical Problem (1384); Product Quality Problem (1506); Application Program Problem (2880)
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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 does not close well and resets itself from 138ml to 100ml volume.No patient injury reported.
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Manufacturer Narrative
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Other text: b3.Date of event is unknown.H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one device was received.A visual inspection found the tamper seals removed and a peeling downstream sensor seal.No evidence of the customer reported issue was found in the event history log.During the functional testing, the customer reported problem of the pump resetting itself was able to be duplicated.The problem was found to be caused by the main board battery.It was recommended to charge the pump for three days.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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