Catalog Number 05342716001 |
Device Problems
Thermal Decomposition of Device (1071); Circuit Failure (1089); Sparking (2595)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/15/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation is on-going.A follow-up report will be submitted upon the completion of the investigation.
|
|
Event Description
|
A customer from the united states reported while performing a cleaning cycle, an odor was noticed coming from the benchmark ultra instrument and could see some smoke coming from between the center panel and drawer #15.As a precaution, the instrument was shut down and disconnected from its power source.When a roche field specialist went to the customer for the reported issue, evidence of thermal damage was observed on the circuit board.There was no need to evacuate the lab and no users needed any medical attention.No harm or injury alleged.
|
|
Manufacturer Narrative
|
Further investigation is needed to determine the root cause(s) of the alleged issue.No harm alleged.The pcba cell bus was replaced and the instrument is working as intended.Device code was updated to sparking.
|
|
Manufacturer Narrative
|
Investigation concluded that the service action resolved the issue.Updated and replaced the device codes, evaluation method codes and evaluation result and conclusion codes.
|
|
Search Alerts/Recalls
|