Model Number H45051PB (CABLE) |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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No report of patient involvement.Udi: (b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).
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Event Description
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Gehc received a report from a customer that the user was removing the venue go power cord from the system when the cable of the female-end/system-end of the venue go power cord separated from the plug exposing electrically energized wires.No injury occurred.The damaged cable was disposed by the customer and is unavailable for evaluation.
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Manufacturer Narrative
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Gehc's investigation has completed.The customer provided photos of the damaged power cord which were assessed by gehc and the manufacturer of the power cord.Additionally, the manufacturer of the power cord evaluated production material and processes as part of the investigation.The conclusion was that power cord manufacturer production processes and raw materials are within specifications and there is no indication these would have contributed to the failure of the power cord.Thus the most likely cause is stress damage from pulling, bending, blows and/or smashing to the strain relief & cable while in the potentially chaotic emergency room environment the system is in.The issue was corrected by replacing the damaged power cord upon failure.Gehc's risk assessment concluded that mitigations in place are sufficient and at an acceptable level, and no further actions are required at this time.
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Search Alerts/Recalls
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