Catalog Number 0250080617 |
Device Problem
Device Packaging Compromised (2916)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.(b)(4).
|
|
Event Description
|
It was reported that the insulation had been compromised.
|
|
Manufacturer Narrative
|
Alleged failure: cib derrick pcs insulation broken.(b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be third party repair.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
|
|
Event Description
|
It was reported that the insulation had been compromised.
|
|
Search Alerts/Recalls
|