MalfunctionDPW
MAQUET CARDIOPULMONARY AG
Received May 22, 2015 · Event occurred May 18, 2015
Report 8010762-2015-00662 · MDR key 4798447
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT CUSTOMER STATED THE SINGLE PUMP WOULD DISPLAY AN INTERMITTENT BELT SLIP ERROR THAT PROGRESSIVELY GOT WORSE OVER TIME. PUMP IS USED IN A TEACHING CLASS AND NOT ON ANY PATIENTS. PUMP TO BE SENT TO THE NATIONAL REPAIR CENTER IN (B)(4) FOR SERVICE. (B)(4).
Additional Manufacturer Narrative
(B)(4). MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING SIMILAR MALFUNCTION, HAVE TESTED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER RECEIVING NEW INFORMATION.