Model Number 8120 |
Device Problems
Break (1069); Corroded (1131); Crack (1135); Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189); 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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The customer reported the device was broken/damaged.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 crack front cover, rear case, barrel clamp and lock label.Replaced broken left iui and corroded right iui.The failure code othe was used to track the alaris 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 21aug2007.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 probable cause of the reported issue was due to broken/damaged front cover pca.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.
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Event Description
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The customer reported the device was broken/damaged.There was 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 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 21aug2007.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 the device was broken/damaged.There was no patient involvement.
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Search Alerts/Recalls
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