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Model Number FGS-0313 |
Device Problems
Signal Artifact/Noise (1036); Detachment of Device or Device Component (2907); Unintended Application Program Shut Down (4032)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/31/2019 |
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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According to the reporter, they had a short study.Technical support logged into the customer's computer and confirmed that instead of 48 hours, the study was only 23:50 hours and there were also a number of "ignores" in the study because the capsule fell off.The recorder worked correctly during the previous procedure.There was no patient and user harm and a repeat procedure was necessary.
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Manufacturer Narrative
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Evaluation summary: this report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, a study graph was provided by the customer for analysis.The customer reported they had a short study.The reported condition was confirmed.The investigation found that the reported condition was due to bravo system communication failure.The investigation isolated the failure to the bravo communication system, but a cause was not identified.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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