Model Number 8220 |
Device Problems
Break (1069); Contamination (1120); Crack (1135); 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.Device is pending evaluation.
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Event Description
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The customer reported that the device has a broken case.There was no patient involvement.
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Event Description
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The customer reported that the device has a broken case.There was no patient involvement.
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Manufacturer Narrative
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The investigation is still 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 has a broken case.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 rear case, front case, right iui, contaminated patient connector pcb, left iui and lifted keypad.This file is reportable based on the finding of contamination of the device iui.A review of the device history record for (b)(6) was performed, which showed the device had a manufacture date of 15aug2012 and confirmed that this device was not involved in a production failure which correlates to the customer reported issue.The review was performed from the date of manufacture to the date of product release for distribution.A review of the complaint history record 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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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 rear case, front case, right iui, contaminated patient connector pcb, left iui and lifted keypad.The failure code othe 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 15aug2012.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 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 that the device has a broken case.There was no patient involvement.
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Search Alerts/Recalls
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