Model Number 8120 |
Device Problems
Failure to Analyze Signal (1539); Failure to Read Input Signal (1581); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The actual date of event is unknown.Device evaluated by bd service.A review of the complaint history for sn (b)(4) 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 25apr2019.The review was performed from the date of manufacture to the present date 09jun2021.A review of the device history record for sn (b)(4) 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)(4) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.Device was not returned to manufacturing facility.
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Event Description
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It was reported that the device had alarm error codes/messages error code 353.6650.The binary sensors and the barrel clamp open and flange detector failed the open tests.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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Event Description
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It was reported that the device had alarm error codes / messages error code 353.6650.The binary sensors and the barrel clamp open and flange detector failed the open tests.There was no patient involvement.
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Search Alerts/Recalls
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