Model Number 8220 |
Device Problems
Break (1069); Contamination (1120); Appropriate Term/Code Not Available (3191)
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Patient Problem
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 was broken/ damaged, broken connector.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 was broken/ damaged, broken connector.No additional information was provided.There was no patient involvement.
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Manufacturer Narrative
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A review of the complaint history record was performed for the 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 14apr2015.The review was performed from the date of manufacture to the date of product release for distribution.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.
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Event Description
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It was reported that the device was broken/ damaged, broken connector.No additional information was provided.There was no patient involvement.
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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 patient connector pcb.Replaced contaminated left iui and broken right iui.The failure code other was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.A review of the device history record showed the device had a manufacture date of 14apr2015.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 broken patient connector pcb.A review of the complaint history record in trackwise and sap was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
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Search Alerts/Recalls
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