More information has been requested from the customer "there are no visual signs of burning that i can see." there are no signs of smoke damage or melting on the stim device - waiting for update on questions asked.A quote has been sent to the customer for a repair - technical service are to provide an update.Justification for not providing below information and applicable sections: patient information - no patient injury initially reported, device malfunction occurred, natus has reached out to confirm this.Date of event - information not known on the initial report date and has been requested.Relevant tests / laboratory data - this section is not applicable as no patient injury initially reported.Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury reported initially.Lot # - this section is not applicable as the medical device does not have a lot number.Expiration date - information not available at the time of the report this will be submitted in the follow up report.If implanted or explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient.Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device.Manufacture date - information not available at the time of the report this will be submitted in the follow up report.If remedial action initiated , check type - this section is not applicable as no remedial action was initiated.If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21usc 360i(f).
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