|
Model Number FGS-0313 |
Device Problem
Failure to Calibrate (2440)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 06/06/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, they had a capsule which failed to calibrate.The customer advised that they have tried to troubleshoot the issue by swapping the recorders and solution, but they are still unable to calibrate the capsule.The capsule will be returned for investigation.There was no patient involvement, but a repeat procedure will be necessary due to the alleged device malfunction.
|
|
Manufacturer Narrative
|
Evaluation summary the customer reported they had a capsule which failed to calibrate.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.The product tested satisfactory.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Corrected information: if information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|