Model Number 8300 |
Device Problem
Device Alarm System (1012)
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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 device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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It was reported that the device received an alarm - error code message.The error code displayed was 9.100.1318.There was no patient involvement.
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Manufacturer Narrative
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Technical support performed troubleshooting over the phone to determine the customer reported issue of npi 8300 error 9-100-1318.Based on the troubleshooting results, technical support determined the proximate cause of the customer¿s reported issue.Technical support: 1.Flash software.2.Replace logic board.3.Return the module to the factory.Biomed is flashing unit.If flashing fails, biomed will call back for a repair rma.A review of the device history record showed the device had a manufacture date of 06 sep 2017.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.There were no existing capa¿s listed for any of the parts listed in this file for repair.H3 other text : no product returned.
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Event Description
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It was reported that the device received an alarm - error code message.The error code displayed was 9.100.1318.There was no patient involvement.
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Search Alerts/Recalls
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