COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION INREACH SYSTEM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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Model Number AAS00161-12 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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Field service was completed and the issue was replicated as customer reported.The industrial personal computer (ipc) was replaced.The ipc has not yet been returned and/or evaluated.Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.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 system computer would not power on fully and remain on.They manually powered it on but it immediately shut down again.They powered the system off and on several times, but it kept shutting down.The patient was under general anesthesia and the physician cancelled the case.There was no adverse event to the patient.
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Manufacturer Narrative
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Complaint confirmed.The ram module in dimm1 failed, preventing the ipc from booting properly.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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