Model Number MAXFAST |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problems
Death (1802); Pressure Sores (2326)
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Event Date 06/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the device caused a burn or abrasion, or pressure ulcer type of wound to the patient 's forehead.It was reported that they had a patient that was in very poor health in the icu with high blood pressure, poor perfusion, ventilated, and having their o2 saturation monitored with the sensors.
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Event Description
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According to the reporter, the device caused a burn or abrasion, or pressure ulcer type of wound to the patient 's forehead.It was reported that they had patient that was in very poor health in the icu with high blood pressure, poor perfusion, ventilated, and having their o2 saturation monitored with the sensors.It was reported that the wound was evaluated and determined it was not pressure related.The wound leave open to air, and apply medicated ointment, the area did heal and begin to look better within days.Patient expired but not related to this concern.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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