ST PAUL BCI MULTIPARAMETER MONITOR BCI ADVISOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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Model Number 9200 |
Device Problems
Defective Alarm (1014); Unable to Obtain Readings (1516)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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B3: date of event is unknown, no information has been provided to date.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that if patient goes into a fib, the device will not register or alarm.No report of patient involvement.
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Manufacturer Narrative
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H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One product was received.Visual inspection noted the ?tamper? sticker was intact and no impact or corrosion damage was present.Functional testing involved an electrocardiogram (ecg) simulator test.Could not duplicate the issue.Received electrocardiogram (ecg) readings via the simulator and monitor alarms when the readings violate the alarm limits.Electrocardiogram (ecg) function is operating within factory specifications.A device history record (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.Replaced the electrocardiogram (ecg) cable as a preventative measure.
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Search Alerts/Recalls
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