Model Number PM3562 |
Device Problems
Failure to Interrogate (1332); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the device could not be interrogated using wireless telemetry.The device switched appropriately from an inductive to radio frequency (rf) communication, but rf communication could not be completed with any strength to complete interrogation.There was no patient involved.The device was not used.
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Manufacturer Narrative
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Customer complaint of radiofrequency (rf) communication anomaly was not confirmed.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found.¿device was received in backup mode.Device image analysis found the cause of backup to be u2 xena anomaly likely due to exposure to cold temperatures.Product code was downloaded, and analysis was performed.Backup operation was reproduced at cold temperature and this is consistent with xena ic anomaly.Assessment of total projected longevity was performed and device was in normal range of operation with appropriate longevity remaining.
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Manufacturer Narrative
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Correction: section 6 - investigation conclusions should have been " 4307 - cause traced to component failure" rather than " 4315 - cause not established".
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Search Alerts/Recalls
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