MalfunctionKDP
VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Dec 14, 2012
Report 8010762-2014-01037 · MDR key 4463295
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70103.5905Catalog number
70103.5905
Product problems
- Unstable
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
ON (B)(6) 2012 (B)(6) REPORTED THAT THE VACUUM WAS UNSTABLE ON THE VACUUM CONTROLLER (VAVD) SERIAL NUMBER (SN): (B)(4). (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. A DIAPHRAGM/MEMBRANE CONTROL DURATION TEST WAS PERFORMED AND THE DEVICE WAS TESTED PER THE SERVICE PROTOCOL BUT THE FAILURE WAS NOT REPRODUCED. (B)(4).