Evaluation summary: though no equipment was received for evaluation, a copy of the study was provided.Based on the data that was collected during the procedure, the recording was 69:10 hours in duration of a scheduled 96 hours.For the duration of the recording gaps in the signal were noted.As no equipment was returned, the cause of the failure cannot be reliably determined, but could have been caused by the following: a.Recorder malfunction ¿ due to a failure in the internal components inside the recorder, the ability to pick bravo capsule signal was damaged b.Capsule failure - due to failure on capsule¿s internal components, the ability of the capsule to function properly was damaged c.It can be some systematic communication error between capsule and recorder a review of the device history record indicates that the product was released meeting finished product specification.If information is provided in the future, a supplemental report will be issued.
|
According to the reporter, they have a study with multiple large gaps in the tracing.Technical support was able to connect to the customer's computer and transfer a copy of the study for review, which confirmed there were several large gaps.There was no harm to the patient or the user, but a repeat procedure is necessary due to the device failure.
|