MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
|
Back to Search Results |
|
Model Number BI70002000 |
Device Problem
Failure to Run on Battery (1466)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/20/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluated by mfr: a representative went to the site to preform system check out.It was noted that there was an electrical issue.They replaced all the batteries, power conversion, charging enclosure and power tray.The system preformed as intended.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information regarding a imaging system used outside of a procedure.It was reported that after the system was powered on it then powered off and showed that the system only had one bar on the charging level and was flashing a blue charge level.The representative stated that the system was plugged in and had been charging all day and night into a known active outlet.There was no patient present.
|
|
Manufacturer Narrative
|
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: kit svc o2 bi71000176 encl power convsn, lot/serial: rev.2 : s/n (b)(6).H3, h6: the power enclosure conversion was returned to medtronic for analysis.Testing was conducted and the product failed bench testing fdm b01, fdr c02, and fdc d02 are applicable to the power enclosure conversion analysis.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.
|
|
Manufacturer Narrative
|
H3: the charger enclosure was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed with the returned charger enclosure.It was found that it was dusty, but once cleaned and installed in a known good system, it performed as intended.H6: c19 and d14 are associated with the charger enclosure.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.
|
|
Search Alerts/Recalls
|
|
|