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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The customer reported ecom send/receive timeout error.There was no patient involvement.
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Manufacturer Narrative
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Additional information: a1, h3, h6, h10.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 (b)(6) 2017 to the present date (b)(6) 2021 and confirmed that this device was not previously returned for servicing.
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Event Description
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The customer reported ecom send/receive timeout error.There was no patient involvement.
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Event Description
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The customer reported ecom send/receive timeout error.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 reconnected tubing for error 570.6200.Replaced broken right iui.Replaced etco2 door for it get stuck.A review of the device history record for sn (b)(6) was performed from the date of manufacture 08/17/2017 to the present date 01/20/2021 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 kinked tubing of the oridion board.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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Search Alerts/Recalls
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