Model Number 01-07-2101 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/09/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A review of the manufacturing records indicated that the product met specifications upon release.
|
|
Event Description
|
It was reported that this foresight sensor was not reading correctly.Follow-up is ongoing for further information.No patient injury has been reported.The product was available for evaluation.Patient demographics were unable to be obtained.
|
|
Manufacturer Narrative
|
Further investigation determined that this is a duplicate complaint.This was previously reported under medwatch 2015691-2020-12196.This complaint will be voided.
|
|
Search Alerts/Recalls
|