MalfunctionBTM
AIRFLOW
Received Sep 26, 2019 · Event occurred Aug 29, 2019
Report 1314417-2019-00050 · MDR key 9124783
Device
Generic name
Manual Resuscitator
Manufacturer
Sunmed Holdings Llc.Model number
AF1140MB-PLot number
318557
Product problems
- Connection Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED, AND THE MASK PORT WAS CONFIRMED OUT OF ROUND VIA A VISUAL INSPECTION. CUSTOMER COMPLAINT WAS CONFIRMED.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT "MASK CONNECTION IS MISSHAPEN." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.