Model Number CD3249-40Q |
Device Problems
Defective Alarm (1014); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2019 |
Event Type
Injury
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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 patient did not feel a vibratory notifier and has presented to clinic with device at eri.It was suggested testing the notifier in clinic under both inductive and rf telemetry.The test was performed and neither the clinician or the patient could feel it vibrating.On (b)(6) 2019, the device was explanted and replaced.The patient was fine.
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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New information notes that the device is part of the premature battery depletion advisory.
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Manufacturer Narrative
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The reported field event of vibratory notifier anomaly was not confirmed in the laboratory.The device was at eri upon receipt but had not yet reached eri when explanted.The device was tested on the bench and no anomalies were found.
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Event Description
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Information received also notes that the device did not alert eri on remote website.
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Search Alerts/Recalls
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