H10: good faith effort was made to determine if the device will be returned for evaluation.The device will not be returned for evaluation.The hospital's biomed concluded the device functioned as intended."the event was not related to any unexpected failure of philips equipment.Philips equipment did what it was supposed to do, no issues with the operation of the equipment." pg 135-136 of the instructions for use (ifu) contains information on battery power including lifetime management.The hospital's biomed stated, "we have it worked out.From the equipment side all is working.It¿s up to nursing next steps for monitoring." the device remains at the customer site.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : the device will not be returned for evaluation.
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