|
Model Number N/A |
Device Problems
Melted (1385); Battery Problem (2885); Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/05/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
This event has been recorded by zimmer biomet under (b)(4).G2 foreign: finland evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
|
|
Event Description
|
It was reported that before surgery, when the nurse took the pulsavac plus wound debridement system out of the outer packaging, the nurse noticed a melted battery pack and a lot of black stains inside the package.The inner packaging was intact.There was no patient involvement with no harm or delay reported.Due diligence is complete.No additional information is available.No adverse events were reported as a result of this malfunction.
|
|
Search Alerts/Recalls
|
|
|