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Model Number IPN000320 |
Device Problems
Electrical /Electronic Property Problem (1198); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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Reported as "electrical malfunction/power off and on and screen flashing black/white".The report states that the "electrical malfunction/power off and on and screen flashing black/white.Issue occurred during use on patient, as a result the pump was swapped out.There was no report of patient complications, serious injury or death.".
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Additionally no recorder strip was returned for investigation.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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Reported as "electrical malfunction/power off and on and screen flashing black/white".The report states that the "electrical malfunction/power off and on and screen flashing black/white.Issue occurred during use on patient, as a result the pump was swapped out.There was no report of patient complications, serious injury or death.".
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Search Alerts/Recalls
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