Model Number 09-1462-0056 |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/06/2018 |
Event Type
Injury
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Event Description
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Prior to the procedure, the amplifier was emitting a beeping tone that could not be resolved and the procedure was cancelled.Troubleshooting was attempted with no resolution and the procedure was rescheduled.The patient was not prepared but was in the room at the time of cancellation.There were no adverse consequences to the patient.
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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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported self test issue and subsequent procedure cancellation could not be determined.
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Manufacturer Narrative
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Additional information: the reported complaint of loss of communication was confirmed.As received, the returned ep-workmate scu powered on but no communication was established due to an unseated single board computer (sbc) board.The displaced board was properly seated and successful communication was restored.The communication test was run for several hours and no interrupted or loss of communication was observed.The reported communication issue and subsequent procedure cancellation was due to the unseated single board computer (sbc).
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Search Alerts/Recalls
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