MAQUET CARDIOPULMONARY AG
Received Oct 8, 2013 · Event occurred Sep 9, 2013
Report 8010762-2013-00050 · MDR key 3459118
Device
Generic name
Hl 20 4-pumps Console Base
Manufacturer
Maquet Cardiopulmonary AgModel number
70102.8580Catalog number
NA
Lot number
NA
Product problems
- Failure To Run On AC/DC
- Inadequate Service
Patient
NA
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. MAQUET (B)(4) HAS PERFORMED AN INVESTIGATION BY REMOTE DIAGNOSIS. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. THE DEVICE WILL BE REPAIRED ON SITE BY A SERVICE TECHNICIAN. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.
Description of Event or Problem
IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE SERVICE AN ELECTRICAL SHORT DEVELOPED. THE CABLE AND INSULATION BECAME CRUSHED BETWEEN THE CASE AND BASE OF THE MACHINE DURING THE REPAIR WORK. INITIAL ELECTRICAL TESTING DID NOT INDICATE AN ELECTRICAL SHORT. OVER A PERIOD OF TEN DAYS, THE INSULATION BROKE DOWN AND CAUSED THE RESIDUAL CURRENT DEVICE (RCD) TO TRIP DURING MOVEMENT OF THE MACHINE. THE EQUIPMENT COULD BE RUN ON A BATTERY BUT COULD NOT BE CONNECTED TO THE MAIN DUE TO THE SHORT. THE PERFUSIONIST INDICATED THE MALFUNCTION DID NOT OCCUR DURING A PROCEDURE. REFERENCE: (B)(4).