Model Number 8300 |
Device Problems
Break (1069); Contamination (1120); Crack (1135); Failure to Cycle (1142); Communication or Transmission Problem (2896); 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 by the customer that the device received alarm - error codes / messages, error code 570.5600.There was no patient involvement.
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Event Description
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It was reported by the customer that the device received alarm - error codes / messages, error code 570.5600.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 oriidon pcb for error 570.6200.Replaced broken front case.Replaced dented rear case.Replaced etco2 door for won't close/stuck.Replaced contaminated left iui.Replaced broken right iui.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 11sep2014.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 root cause of the reported issue was due to electrical failure of the oridion board assembly.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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Search Alerts/Recalls
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