Unit passed all functional tests including displacement, rewind, prime/seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement, and self tests.No unexpected suspend alerts were noted.Thus software was utilized and uploaded trace/history files properly.The adapt tool confirms multiple occurrences of the following delivery related alerts/alarms around the event date: 12=auto suspend occurred on 02/21/2022 @ 11:56:00 & 12:06:00.The adapt tool also does not list any pump errors that could potentially trigger a critical pump error whatsoever.The case was cut open.After visual inspection, did not note any signs of previous moisture presence or corrosion inside the battery compartment or on any of the boards, assemblies, and the motor inside the unit.In summary, customer claim that the unit suspends itself randomly was confirmed in the unit's history file.The adapt tool lists the cause of the 12=auto suspend as a possible hardware problem.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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