Model Number MAX-I-I |
Device Problem
Low Readings (2460)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 07/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: max-i-i max inf o2 sensor i20 3-20 kg (lot# 231700140h) 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, the sensor had low spo2 reading that could be seen on different monitors.It was checked with two different saturation simulators which resulted that as lower the saturation was set, a higher was the deviation downwards.Due to the incorrect readings (a high downward deviation), an unnecessary bga was performed and the sensor was change.
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Manufacturer Narrative
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Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the monitor provided lower oximetry readings than expected.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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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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, the sensor had low spo2 reading that could be seen on different monitors.It was checked with two different saturation simulators which resulted that as lower the saturation was set, a higher was the deviation downwards.Due to the incorrect readings (a high downward deviation), an unnecessary bga was performed and the sensor was change.It was reported that, due to the spo2 values seem to be very low the hcp checked this in relation to other vital signs, which all were okay.Due to these events occurred on a nicu/picu we were not able to check this again at a patient, so we used a simulator as already described.They used new sensors for investigation and the issue occurred also.Sensor placed at the patients foot and the baseline were the values when incident occurred was between 7-20% (depends on the level of saturation).Spo2 under alarm limit and was in silent mode.During surveillance of the patient; during testing with simulator, no bga data available due to data restrictions, no exact patient number.A new sensor was used and changing to a new sensor was mostly effective.There was no harm just because ot the professionalism of the hcp (spo2 readings did not match the other vital signs.
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Event Description
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According to the reporter, the sensor had low spo2 reading that could be seen on different monitors.The first sensor was placed at the patient's foot and the baseline values were between 7-20% (depends on the level of saturation).Spo2 was under alarm limit and was in silent mode.Due to the incorrect readings (a high downward deviation), an unnecessary arterial blood gas (abg) was performed.The second sensor was used for investigation but the issue also occurred.It was checked with two different saturation simulators which resulted that as lower the saturation was set, a higher was the deviation downwards.Third sensor was used and it worked effectively.
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Manufacturer Narrative
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Additional information: b5, d9, g3, h3, h6 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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Search Alerts/Recalls
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