Model Number 8300 |
Device Problems
Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Peeled/Delaminated (1454); Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/25/2021 |
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.Device was not returned to manufacturing facility.
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Event Description
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It was reported that the device had keypads are delaminating.There was no patient involvement.
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Manufacturer Narrative
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Omit: a07 - electrical /electronic property problem (1198), b17 - device not returned, c20 - no findings available.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 23jun2006.The review was performed from the date of manufacture to the present date 19jul2021.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 keypads are delaminating.There was no patient involvement.
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Search Alerts/Recalls
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