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Model Number 90050 |
Device Problems
Device Damaged Prior to Use (2284); High Readings (2459); Incomplete or Inadequate Connection (4037)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: 90050, 90050 400 general purpose sensor 9 x50 (lot#21b0689jzx).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 product produced more heat than expected, the components failed to connect correctly and there was damage to the unit.The reported issues 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.The instructions included with this device provide the following guidance: do not use if package is opened or damaged.Use only with compatible interconnect cables and monitors.Not doing so may result in an inaccurate measured temperature.Do not modify this device.Modifications could result in inaccurate temperature measurement.Do not attempt to force connection of the sensor.The connectors are keyed by shape.Forcing the connection could result in damage to the sensor or cable connector and a resulting inability to function.Ensure that the cable connector does not lie in an area where solutions may pool during the surgical procedure.This report is being submitted as part of a retrospective review and remediation per crp no.1000199834/nc36.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 a procedure, the device had temperature results issue and a damage connector.The thermal probe fi rst recorded a temperature of 34.1 degrees in the patient and then the temperature rose sharply (in less than 2 minutes) to 40.5 degrees suspecting a potential malignant hyperthermia in the patient.After control by tympanic thermometer, the temperature was 35.1 degrees in each ear.The thermal probe was then removed. unfortunately, this is not the first time that this type of thermal probe has found erroneous data. in addition, when removing the thermal probe, the connector separated from the rest of the thermal probe and got stuck on the cable connecting to the scope (as with each removal) complicating the change of thermal probe.It was then not possible to put back a thermal probe, the thermal monitoring was interrupted for this patient.There was no reported patient outcome.
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Search Alerts/Recalls
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