|
Model Number 7211010F |
Device Problem
Increase in Pressure (1491)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/22/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference: case-(b)(4).
|
|
Event Description
|
It was reported that, during set up or inspection for an unknown procedure, the control unit was overpressuring.The procedure was completed with a smith and nephew back up device.No patient injury, delays or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
|
|
Search Alerts/Recalls
|
|
|