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Model Number RFB-0450 |
Device Problems
Loss of Power (1475); Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/26/2018 |
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, ten and a half hours after capsule placement, the recorder displayed error code ¿386err_j2c024/driver¿ and it turned off.The customer press and hold power button for 30 seconds, but there was no response.The customer then pressed circle, triangle, square and circle buttons, but there was no change in error state.A repeat procedure will be performed.The customer noted that the recorder worked correctly during previous procedure.There was no patient injury.The device will be returned for data extraction.
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Manufacturer Narrative
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Additional information: evaluation summary: this report is based on information provided by medtronic investigation personnel.The bravo recorder was received for evaluation.The returned sample met specification as received by medtronic.The visual inspection found no issues.The customer reported that ten and half hours after capsule placement, the recorder displayed error code ¿386err_j2c024/driver¿.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.The investigation could not determine a cause or a probable root cause for the customer's report based on the information provided.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, ten and half hours after capsule placement, the recorder displayed error code ¿386err_j2c024/driver¿ and it turned off.The customer press and hold power button for 30 seconds, but there was no response.The customer then pressed circle, triangle, square and circle buttons, but there was no change in error state.A repeat procedure will be performed.The customer noted that the recorder worked correctly during previous procedure.There was no patient harm.The device will be returned for data extraction.Technical support received, disassembled and tested the recorder broke down when they were attempting to extract information.After many attempts data was downloaded via software version 6.
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Search Alerts/Recalls
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