MalfunctionCBL
MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE
Received Jul 13, 2020 · Event occurred Mar 2, 2020
Report 3002807637-2020-00006 · MDR key 10268600
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Vyaire MedicalModel number
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLECatalog number
8003138
Lot number
2960619
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AS OF THIS TIME, NO SAMPLES WERE RETURNED YET. BUT THE CUSTOMER CONFIRMED THA THE SAMPLES IS AVAILABLE FOR EVALUATION. 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 RESPIRATOR DETECTS LEAKS AND BLOCKS THE TEST WHEN CHANGING THE MEDISORB SODA LIME DURING PATIENT USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.