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Model Number 450-0034 |
Device Problem
Power Problem (3010)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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The device had been returned under a service work order (sro) during which it was identified that the device was continuously running due to malfunction of the flex circuit in the cable assembly.The device was repaired under the sro and was subsequently tested and met specifications.The device is a reusable device.Attempts are being made to obtain further information regarding the findings of the sro, and a follow up report will be submitted if additional information is received and/or after completion of the investigation.Mdr submission timeline affected by data entry timeliness of the device diagnosis within the diagnosis/repair log.This diagnosis/repair log is reviewed on a weekly basis, and the data entry oversight resulted in the diagnosis of this device not being observed on the log until the weekly review performed on 10 february 2023.Actions are being taken to mitigate the data entry timeliness.
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Event Description
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A service request for the device was received with no product complaint made.On 09 january 2023, the service request work order device diagnosis was completed.During the service request work order, it was noted the device was running continuously due to a malfunctioning flex circuit in the cable assembly.As a result of these findings of the service request work order, this report is being submitted.Additionally, as a result of the service request work order, the customer is being contacted to obtain additional information regarding these findings.
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Manufacturer Narrative
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Manufacturing and inspection records were reviewed.All inspections passed and no issues were identified in the device history record review.The device was returned per service work order (sro) s000053005 and subsequently tested after repair.All specifications were met.The diagnosis during the work order was identified to be "unit runs continuously due to a malfunctioning flex circuit in the cable assembly." the device is a reusable instrument and was manufactured in 2020; therefore, it is unknown how many times the device was used prior to this reported complaint event nor under what circumstances it was used.No additional information regarding this event has been received.Therefore, the root cause of the issue could not be determined.
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Search Alerts/Recalls
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