Model Number 8300 |
Device Problem
Physical Resistance/Sticking (4012)
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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 device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.
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Event Description
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It was reported that the device has damaged front and rear cases.No additional information was provided.There was no patient involvement.
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Event Description
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It was reported that the device has damaged front and rear cases.No additional information was provided.There was no patient involvement.
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Manufacturer Narrative
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The investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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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 replaced broken front case, rear case and right iui.Replaced contaminated left iui.Replaced etco2 door for it getting stuck.A review of the device history record showed the device had a manufacture date of 08/28/2012.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.Based on the findings, service determined that the proximate cause of the reported issue was due to customer damage of the front & rear case - damaged/ cracked (upper left/ right corner).A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.There are capa #'s noted for the following parts replaced that have an already existing capa.Ca-2018-0161 iui conn issues.
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Event Description
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It was reported that the device has damaged front and rear cases.No additional information was provided.There was no patient involvement.
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Search Alerts/Recalls
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