Model Number 450-0034 |
Device Problem
Power Problem (3010)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Event Description
|
A service request for the device was received on (b)(6) 2022 with no product complaint made.On (b)(6) 2022, the service request work order was completed.During the service request work order, it was noted the device was running continuously due to a malfunctioning 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.
|
|
Manufacturer Narrative
|
The device history record (dhr) was reviewed, and no anomalies were found.The review revealed the device had been tested and met specifications.Additionally, all inspections had passed.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 cable assembly.The device was repaired under the sro and was subsequently tested and met specifications.The device is a reusable instrument and was manufactured in 2017.Therefore; it is unknown how many times the device was used prior to this reported complaint event nor under what circumstances it was used.Based on the information available, the root cause could not be determined.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.
|
|
Manufacturer Narrative
|
Additional information received on 15 june 2022 after follow up attempts to obtain more information following the findings of the service repair.It was reported on 15 june 2022 that the issue with the device was the "lever arm motor unit was not working".No further information regarding how it was not working and the circumstances surrounding this issue was provided or available.
|
|
Manufacturer Narrative
|
H6: type of investigation- corrected to 10 (testing of actual/suspect device) and 3331 (analysis of production records).4117 (device not accessible for testing) was selected in error.
|
|
Search Alerts/Recalls
|