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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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Event Description
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A service request for the device was received with no product complaint made.On 21 june 2022, 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 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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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 device and was manufactured in 2018; 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.
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Manufacturer Narrative
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Additional information regarding the event received on 26 july 2022.Additional information received indicated the hospital requested repair of the device because the item was damaged likely due to falling and breaking.It was also reported there was no patient involved,.
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Search Alerts/Recalls
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