Model Number 8300 |
Device Problem
Failure to Cycle (1142)
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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 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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It was reported that the device received an alarm - error code message.The error code displayed was 571.6241.There was no patient involvement.
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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 571.6241.There was no patient involvement.
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Manufacturer Narrative
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The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.A review of the device history record for sn (b)(6) was performed from the date of manufacture 10/09/2017 to the present date 01/19/2021 and confirmed that this device was not previously returned for servicing.Also, there were no production failures indicated on the source device.
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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 571.6241.There was no patient involvement.
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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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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 reconnected ferrite cable into power supply connector for channel error 571.6241.Replaced broken rear case.Replaced etco2 door for it get stuck.Replaced contaminated left iui.A review of the device history record for sn (b)(6) was performed from the date of manufacture 10/09/2017 to the present date 01/19/2021 and confirmed that this device was not previously returned for servicing.Also, there were no production failures indicated on the source device.Based on the findings, service determined that the proximate cause of the reported issue was due to a loose ferrite cable.The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.There are capa #'s noted for the following parts replaced that have an already existing capa.Ca-2018-0161 for iuis.
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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 571.6241.There was no patient involvement.
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Search Alerts/Recalls
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