VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Jan 25, 2013
Report 8010762-2014-01038 · MDR key 4461738
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70102.2005Catalog number
70102.2005
Product problems
- Leak/Splash
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
ON (B)(6) 2013 AT (B)(6) REPORTED THAT THE VACUUM CONTROLLER (VAVD) SERIAL NUMBER: (B)(4) HAD INTERMITTENT LEAKAGE ISSUES. A COUPLE OF MEMBRANE KITS WERE FITTED AND THE CONTROLLER WORKED FINE FOR WEEKS/MONTHS, THEN FOR NO REASON STRUGGLED TO MAINTAIN VACUUM. ORIGINAL MEMBRANES WERE FOUND TO BE CLEAN & WITH NO SPLITS/DAMAGE. REFERENCE: RMA 7023003260
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 PRESSURE RELIEF WAS CORRECTED AND THE DEVICE TESTED PER THE SERVICE PROTOCOL. (B)(4).