Model Number FGS-0634 |
Device Problems
Failure to Transmit Record (1521); Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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This product is not sold in us and is 510(k) exempt.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, when they tried to upload the study on the recorder, it had an error message stating that there might not be any data on it.There was also a message on the recorder stating that the last study data was not yet uploaded.The malfunction was noticed when they were downloading the data.They got a copy of the error.A repeat procedure scheduled on another day with additional anesthesia was necessary.There was no patient and user harm.
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Manufacturer Narrative
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Evaluation summary: this report is based on information provided by post market vigilance investigation personnel.The product sample was not returned to the medtronic laboratory; however, a data file was provided by the customer for analysis.The customer reported when they tried to upload the study on the recorder, it had an error message stating that there might not be any data on it.The reported condition was confirmed.According to received picture main suspected that the data on the bravo recorder is corrupted for unknown reason.The returned sample did not met specification as received by medtronic.The investigation found the most probable cause to be the data failure.A review of the device history records indicating that the product was released meeting finished product specifications.If information is provided in the future, a supplemental report will be issued.
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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, when they tried to upload the study on the recorder, it had an error message stating that there might not be any data on it.There was also a message on the recorder stating that the last study data was not yet uploaded.The malfunction was noticed when they were downloading the data.They got a copy of the error.A repeat procedure scheduled on another day with additional anesthesia was necessary.There was no patient and user harm.
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Search Alerts/Recalls
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