VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Oct 26, 2011
Report 8010762-2014-01031 · MDR key 4461708
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70102.5905Catalog number
70102.5905
Product problems
- Incorrect Measurement
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
ON (B)(6) 2011 (B)(6) REPORTED THAT THE ACTUAL PRESSURE ON THE VACUUM CONTROLLER (VAVD) SERIAL NUMBER(SN): (B)(4) WHEN MEASURED BY A PRESSURE GAUGE FLUCTUATED BETWEEN +10MMHG AND -10MMHG OF THE SET PRESSURE AFTER SWITCHING THE DEVICE ON AND THEN OFF. THE MEMBRANE WAS REPLACED 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). PER SERVICE ORDER (B)(4) THE MEMBRANE, VACUUM CHAMBER, MAINTENANCE KIT, CYLINDER AND CYLINDER SEALING WERE REPLACED. MAINTENANCE WAS PERFORMED ACCORDING TO THE SERVICE PROTOCOL. (B)(4).
Remedial action
- Repair