ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
Received Jul 13, 2020 · Event occurred Jun 16, 2020
Report 8030673-2020-00103 · MDR key 10268596
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Model number
ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAGCatalog number
ADU520X4D
Lot number
0004143192
Product problems
- Defective Component
- Defective Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: ONE OPENED SAMPLE OF THE P/N ADU520X4D WITHOUT LOT NUMBER WAS RECEIVED FOR THE INVESTIGATION. ACCORDING TO INVESTIGATION, WE DETERMINED THAT PERSONNEL ARE RELATED WITH DEFECT REPORTED, SINCE THEY DID NOT FOLLOW THE PROCESS TO PERFORM CHANGE PROPER THE MEDIA ROLL. ALSO PROCESS IS RELATED WITH DEFECT REPORTED, SINCE IT IS NOT VERY CLEAR TO PERFORM THE CHANGE OF THE ROLL PLUSH.
Additional Manufacturer Narrative
AS OF THIS TIME, HAS BEEN SHIPPED FOR INVESTIGATION. HOWEVER, THE CUSTOMER CONFIRMED THAT THE SAMPLE IS AVAILABLE. AS AN INTERVENTION, AN AMBU BAG WAS REQUIRED TO BE USED UNTIL IT WAS REPLACED WITH A NEW CIRCUIT. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE ADU520X4D VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT EXPERIENCED CIRCUIT MALFUNCTION DUE TO PLASTIC PIECE COVERING THE AIR EXCHANGE CIRCUIT FILTER DURING USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT. AS AN INTERVENTION, A MANUAL VENTILATION WAS REQUIRED TO BE USED UNTIL IT WAS REPLACED WITH A NEW CIRCUIT.