Catalog Number 0620040504 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Pain (1994)
|
Event Date 05/31/2019 |
Event Type
Injury
|
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.
|
|
Event Description
|
It was reported that the patient extended their stay because of post op pain.
|
|
Manufacturer Narrative
|
The product was returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient extended their stay because of pain the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as the unit performed to specification with no errors observed as per the customer complaint.However, the unit is past due for calibration and preventative maintenance.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacture date is not known.
|
|
Event Description
|
It was reported that the patient extended their stay because of post op pain.
|
|
Search Alerts/Recalls
|