Model Number 8300 |
Device Problems
False Alarm (1013); Crack (1135); Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that the device had alarms for no apparent reason continues to get channel error / tried reflashing unit twice and alarm still reoccurs.There was no patient involvement.
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Manufacturer Narrative
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A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation of this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
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Event Description
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It was reported that the device had alarms for no apparent reason continues to get channel error / tried reflashing unit twice and alarm still reoccurs.There was no patient involvement.
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Manufacturer Narrative
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Please note that the initial report for mfr report # 2016493-2022-235228 was submitted for the error code 571.6241 which was observed during device servicing process.This follow-up report is submitted to add clarity to the previous report.Additional imdrf codes are included in this follow-up report to reflect the observed error code.Correction: annex a: a0404 annex g: g04037 annex c: c23 additional information: annex a: a13 annex g: g02004 annex c: c02.
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Event Description
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It was reported that the device had alarms for no apparent reason continues to get channel error / tried reflashing unit twice and alarm still reoccurs.There was no patient involvement.
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Manufacturer Narrative
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A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.H3 other text : see manufacturer narrative.
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Search Alerts/Recalls
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