Model Number 8300 |
Device Problems
Loose or Intermittent Connection (1371); Device Sensing Problem (2917); Appropriate Term/Code Not Available (3191)
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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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Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.
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Event Description
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It was reported that the device had a channel error.No patient involvement.
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Event Description
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It was reported that the device had a channel error.No patient involvement.
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Manufacturer Narrative
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The affected device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.H3 other text : the affected device has been received and an evaluation is pending.
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Manufacturer Narrative
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This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they reconnected ferrite cable into power supply connector for error 571.6241.A review of the device history record showed the device had a manufacture date of (b)(6) 2019.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 (b)(6), was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Based on the findings, service determined that the proximate cause of the reported issue was due to a loose cable.A review of the complaint history record in trackwise and sap was performed for the (b)(6), which confirmed similar complaints with the same or related failure mode for this customer.
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Event Description
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It was reported that the device had a channel error.No patient involvement.
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Search Alerts/Recalls
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