VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Mar 14, 2013
Report 8010762-2014-01039 · MDR key 4461734
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70102.4459Catalog number
70102.4459
Product problems
- Suction Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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 BLOOD WAS PRESENT INSIDE THE DEVICE AND A REPAIR ESTIMATE WAS PROVIDED TO THE SSU. THE SSU REJECTED THE ESTIMATED AND DECIDED TO SCRAP THE DEVICE. (B)(4).
Description of Event or Problem
ON (B)(6) 2013 (B)(6) REPORTED THAT THE (VAVD) SERIAL NUMBER (SN): (B)(4) WAS NOT APPLYING VACUUM AND COULD NOT BE SET TO DESIRED VACUUM. THIS OCCURRED DURING PATIENT TREATMENT. (B)(4).