MalfunctionBTM
AIRFLOW
Received Oct 9, 2018 · Event occurred Aug 20, 2018
Report 1314417-2018-00040 · MDR key 7948519
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Known Impact Or Consequence To Patient
- Missing Value Reason
- No Known Impact Or Consequence To Patient
- Missing Value Reason
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION. AN INVENTORY EVALUATION WAS PERFORMED ON THE SAME PART NUMBER AND NO IRREGULARITIES WERE FOUND. THE INVESTIGATION IS INCONCLUSIVE WITHOUT THE AFFECTED PRODUCT OR PHOTOS OF THE DEVICE.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT " THE MASK ON RESUS BAG WAS DEFLATED." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.