Model Number 8210 |
Device Problems
Device Alarm System (1012); Crack (1135); Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2021 |
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 and not returned to manufacturing facility for evaluation.A review of the complaint history record was performed for the sn (b)(4) 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 28 apr 2007.The review was performed from the date of manufacture to the present date 28 apr 2021.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.
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Event Description
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It was reported that the device displayed error code 200.405.There was no patient involvement.
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Manufacturer Narrative
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Correction: manufacturer narrative (dhr).Additional information: imdrf annex a, g, b, c and d grids and manufacturer narrative (shr).A review of the device history record showed the device had a manufacture date of 28apr2007.The review was performed from the date of manufacture to the present date 07jun2021.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 displayed error code 200.405.There was no patient involvement.
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Search Alerts/Recalls
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