The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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The customer reported that the defibrillation electrodes were connected to a zoll machine for cardioversion.When shock was sent, the connection shorted, sparked, and there was a burning smell.The electrodes did not deliver a shock.There was a delay in care and a minor burn to patient.
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