VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Jan 18, 2012
Report 8010762-2014-01032 · MDR key 4461733
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70102.4459Catalog number
70102.4459
Product problems
- Unstable
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
ON (B)(6) 2012 THE SSU AT MAQUET DENMARK REPORTED THAT THE VACUUM WAS UNSTABLE, BUT THE MANOMETER WAS FUNCTIONING ON THE VACUUM CONTROLLER (VAVD) SERIAL NUMBER (SN): (B)(4). THE CUSTOMER CHANGED OUT THE MEMBRANE BUT THAT DID NOT RESOLVE THE ISSUE. (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. IT WAS DETERMINED THAT THE UNIT WAS REMOUNTED IN THE INCORRECT WAY. THE MOUNTING WAS CORRECTED AND THE DEVICE WAS TESTED PER THE SERVICE PROTOCOL. (B)(4).