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Model Number FGS-0450 |
Device Problems
Communication or Transmission Problem (2896); Missing Test Results (3267)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation: the accuview graph from the study was returned for evaluation.The total time of the study was 52:13 hours as opposed to the recommended study time of 48 or 96 hours.Ph values were found to be normal throughout the study.Because information sent from the customer includes only the accuview graph, the conclusion of the investigation cannot be positively determined.Although a root cause could not be determined, when the recording stops in this manner, it can be caused by the following: recorder battery discharge ¿ if battery was not replaced before beginning of the study.Recorder malfunction ¿ due to a failure in the internal components inside the recorder, the ability to pick bravo capsule signal was damaged.Capsule failure - due to failure on capsule¿s internal components, the ability of the capsule to function properly was damaged or the capsule detached early.A review of the device history record was performed and indicates 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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Event Description
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According to the reporter, they had a short study.A repeat procedure was performed and there was no harm to the patient or user.The recorder worked correctly during the previous procedure.The study was provided for review but no product was returned for investigation.
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Manufacturer Narrative
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Additional information: evaluation summary this report is based on information provided by the global complaint handling system.The product sample was not returned to the medtronic laboratory, however, a accuview graph was provided by the customer for analysis.The customer reported barvo short study.The reported condition was confirmed.The investigation found that total time of the study is 52:13 hours, the ph with normal value but there ware ignores in the graphs.The investigation identified the root cause of the reported event to be bravo system communication failure.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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