Model Number MAXFAST |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Blister (4537)
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Event Date 10/01/2022 |
Event Type
malfunction
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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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Event Description
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According to the reporter, during use, the sensor produced a pressure injury sustained on the occiput (back of the head) from the strap of the sensor used at the back of the head.It was advised that the pressure injuries were caused by a combination of the sensor headband, patient condition and pressure injury prevention measures.Measures have since been taken to reduce the risk and the removal of the sensor was one of those measures.
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Event Description
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According to the reporter, during use, the sensor produced a pressure injury sustained on the occiput (back of the head) from the strap of the sensor used at the back of the head.It was advised that the pressure injuries were caused by a combination of the sensor headband, patient condition and pressure injury prevention measures.Measures have since been taken to reduce the risk and the removal of the sensor was one of those measures.The sensor was placed on the forehead and nil additional forces.Site were checked periodically with rolls and removed when the pressure injury identified.
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Manufacturer Narrative
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Additional information: b5, g3, h3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.The shipping number provided was invalid, and medtronic was unable to confirm that the device had been delivered.Without the device, a detail investigation could not be performed for the reported complaint.If additional information is obtained, or the product is found, this investigation will be re-opened.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that there was not enough information to make any determination.Without the physical product, a definitive cause could not be identified.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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