Model Number 8300 |
Device Problems
Device Alarm System (1012); Crack (1135); 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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The affected devices have not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
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Event Description
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It was reported that the device alarmed and displayed unknown error codes / messages.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 error code 570.6200 is confirmed due to a failed oridion board, replaced it a new oridion board.Updated a new logic board per c.O#1116890.Damaged front case and rear case, replaced them new front and rear cases assembly.Performed leak down test and co2 calibration with passing results.Note: thank you for your patience for the part shortage.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 15aug2013.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 confirmed 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 alarm - error codes / messages.There was no patient involvement.
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Search Alerts/Recalls
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