MAQUET CARDIOPULMONARY AG
Received Mar 18, 2015
Report 8010762-2015-00255 · MDR key 4620299
Device
Generic name
Hl 20 Console Base
Manufacturer
Maquet Cardiopulmonary AgModel number
NICatalog number
70102.7652
Lot number
NA
Product problems
- Noise, Audible
Patient
NI
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED, WHILE PERFORMING A FUNCTION CHECK A CLICKING SOUND OCCURED THAT WAS NOT PRESENT INITIALLY. AFTER OPERATING UNIT OVERNIGHT AT FULL 250 RPM'S CLICKING CEASED. UPON DISASSEMBLY I NOTICED THAT (UPPER) BELT WAS TWISTED AND THE (LOWER) BELT WAS BROKEN. (B)(4).
Additional Manufacturer Narrative
MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE, MAQUET CARDIOPULMONARY (B)(4). PUMP PRODUCT NUMBER: MCP00703309. PUMP SERIAL NUMBER: (B)(4). THE ACTUAL DEVICE HAS NOT BEEN EVALUATED YET. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFO. ITEMS MARKED NI ARE UNKNOWN TO US AT THIS TIME.