VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Sep 30, 2011
Report 8010762-2014-01030 · MDR key 4461703
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70102.4459Catalog number
70102.4459
Product problems
- Contamination
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). PER SERVICE ORDER (B)(4) THE REPAIR QUOTATION WAS NOT ACCEPTED BY THE SSU AND THEREFORE THE DEVICE WAS RETURNED TO THE SSU WITHOUT BEING REPAIRED. (B)(4).
Description of Event or Problem
ON (B)(6) 2011 (B)(6) REPORTED THAT DUE TO A HANDLING ERROR THERE WAS DRIED RESIDUE FROM A LIQUID IN THE PNEUMATIC SYSTEM OF THE VACUUM CONTROLLER (VAVD) SERIAL NUMBER (SN): (B)(4). IT WAS REQUESTED THAT A REPAIR QUOTATION BE SENT BEFORE ANY REPAIR WAS PERFORMED. (B)(4).