Model Number D97130F5 |
Device Problem
Pacing Problem (1439)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/13/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that a pacer did not capture.Catheter was inserted in the femoral artery and placed in the right ventricle vessel.Issue was resolved by exchanging the device with a new swan ganz from the same product line.There was no patient injury.
|
|
Manufacturer Narrative
|
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
|
|
Manufacturer Narrative
|
Multiple attempts were made to secure return of the device however the customer has not responded nor sent the device back for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
|
|
Search Alerts/Recalls
|