MalfunctionKDP
VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Mar 16, 2012
Report 8010762-2014-01033 · MDR key 4461714
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70102.4459Catalog number
70102.4459
Product problems
- Leak/Splash
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
ON (B)(6) 2012 AT (B)(6) IT WAS REPORTED THAT THE VACUUM CONTROLLER (VAVD) SERIAL NUMBER(SN): (B)(4) HAD A VACUUM LEAK. (B)(4).
Additional Manufacturer Narrative
MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). SERVICE REPORT (B)(4) WAS GENERATED FOR THIS EVENT. THE MEMBRANE WAS REPLACED AND THE DEVICE WAS CLEANED AND TESTED PER THE SERVICE PROTOCOL. (B)(4).