MalfunctionKDP
VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Apr 25, 2012
Report 8010762-2014-01035 · MDR key 4461736
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70103.5905Catalog number
70103.5905
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
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) DID NOT FUNCTION AND THE POINTER WOULD NOT GO TO ZERO. (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 FOUND TO BE DAMAGED AND WAS REPLACED. THE DEVICE WAS TESTED PER THE SERVICE PROTOCOL. (B)(4).