Model Number 8120 |
Device Problems
Failure to Analyze Signal (1539); Calibration Problem (2890); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The actual date of event is unknown.A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.
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Event Description
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It was reported that the device had calibration error.There was no patient involvement.
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Event Description
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It was reported that the device had calibration error.There was no patient involvement.
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Manufacturer Narrative
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Device evaluated by bd service.A review of the complaint history for sn (b)(6) was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record showed the device had a manufacture date of 22dec2020.The review was performed from the date of manufacture to the present date 14jun2021.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the service history record for sn (b)(6) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.
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Event Description
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It was reported that the device had calibration error.There was no patient involvement.
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Search Alerts/Recalls
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