ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number H700150 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.¿ further information was requested but not received.
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Event Description
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During the procedure, the amplifier did not communicate as expected.Troubleshooting did not resolve the issue, the amplifier beeped continuously and the case was cancelled.
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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.A review of the device history record was not possible since the amplifier serial number was not provided.Based on the information received, the cause of the reported incident communication issue and subsequent cancellation remains unknown.
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Manufacturer Narrative
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Additional information: one workmate claris amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels had no physical damage.All of the mounting hardware was secured.The returned workmate claris amplifier was powered on but no communication was established with the test computer.The single board computer (sbc) was temporarily replaced with a known good sbc board and successful communication was established.Using the test standard sbc board, the amplifier was run for few hours and no interrupted or loss of communication was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided and the investigation performed, the reported event was due to a non-functional sbc board.
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