VAVD CONTROLLER
Received Jan 29, 2015 · Event occurred Apr 22, 2013
Report 8010762-2014-01040 · MDR key 4461739
Device
Generic name
Regulator, Vacuum
Manufacturer
Maquet Cardiopulmoary AgModel number
70102.4459Catalog number
70102.4459
Product problems
- Device Operates Differently Than Expected
- Noise, Audible
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2013 (B)(6) REPORTED THAT THE (VAVD) SERIAL NUMBER (SN): (B)(4) ALARMED WITH A HIGH VOLUME BEEP WHEN CONNECTED TO VACUUM AND THE SUCTION DID NOT WORK. THIS OCCURRED DURING PATIENT TREATMENT. (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 ALARM BEEP WAS BARELY AUDIBLE WHEN THE DEVICE WAS TESTED. THE BACKPLATE CYLINDER WAS REPLACED AND FUNCTION CONTROL WAS PERFORMED. THE DEVICE WAS TESTED PER THE SERVICE PROTOCOL. (B)(4).