Model Number 989803171961 |
Device Problems
Loose or Intermittent Connection (1371); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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A follow-up report will be submitted once the investigation is complete.
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Event Description
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The customer requested information as to why the st analysis would fail.The record indicates the customer noted waveform gaps and that "no technical alarms for that the electrode come loose or the telemetry unit has lost contact." the device was in use on a patient.There was no report of patient or user harm.
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Search Alerts/Recalls
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