Model Number 8300 |
Device Problem
Failure to Read Input Signal (1581)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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Event Description
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The customer reported that the device failed preventive maintenance.No patient involvement.
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Manufacturer Narrative
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A review of the complaint history record in trackwise and sap was performed for sn (b)(6) , which did not confirm similar complaints with the same or related failure mode for this customer.A review of the device history record showed the device had a manufacture date of 05/26/2006.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap 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.
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Event Description
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The customer reported that the device failed preventive maintenance.No patient involvement.
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Manufacturer Narrative
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A review of the device history record showed the device had a manufacture date of 05/26/2006.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap 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 complaint history record in trackwise and sap was performed for sn (b)(6), which did not confirm similar complaints with the same or related failure mode for this customer.
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Event Description
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The customer reported that the device failed preventive maintenance.No patient involvement.
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Event Description
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The customer reported that the device failed preventive maintenance.No patient involvement.
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Manufacturer Narrative
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Correction: e3, e4.
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Search Alerts/Recalls
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