Model Number 24970A |
Device Problems
Communication or Transmission Problem (2896); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that connection between the device and patient connector lost while using the programmer application.It was noted that the waveform on the electrocardiogram (ecg) dropped out while using the analyzer and through the device and dots showed up instead of waveforms on multiple occasions.It was further noted that signal was lost during a threshold test and the test was stopped due to the patient being potentially dependent.The testing was completed on the third attempt though drops outs still occurred.The programmer remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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