Safety Alert for (1) NEONATAL INCUBATORS MODEL 8000 NC / SC / IC; (2) INFANT RADIANT HEATERS MODELOO RH600; WE. CATALOG: (1) FR00054, 2M21250, 2M21251, 2M21281, 2M21635, 2M21966, 2M21973, 2M21989, 2M220550, 2M220551; (2) 2M20116

Safety alert

164

2000-08-28

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

In case of malfunctioning of the operational amplifier used in the skin temperature measurement circuit, the epithelial temperature probe of the above neonated incubators may super heat. draeger medical declares that excessive heating of the modeloo 8000 incubator probe results, as reported, in burns in a newborn in the united kingdom. draeger medical declares that the same electrical configuration is used in the modeloo rh600 radiant heater. the distributor started a correction by correspondence dated 2 july and 28 august 2000.

MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCES DATED 2 JULY AND 28 AUGUST 2000 AND THE DRAEGER MEDICAL RESPONSE CARD. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DRAEGER MEDICAL RECOMMENDS TO TAKE THE FOLLOWING MEASURES: (1) DO NOT USE THE EPITHELIAL TEMPERATURE SENSORS CONNECTED DIRECTLY WITH THE DRAEGER MODELOO 8000 INCUBATOR OR WITH THE MODELOO RH600 RADIANT HEATER. (2) USE THIS EQUIPMENT ONLY IN ENVIRONMENTAL TEMPERATURE CONTROL MODE. (3) USE A SEPARATE TEMPERATURE MONITOR, IF NECESSARY. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO 8000 INCUBATOR UPGRADE OPTIONS: (1) REQUEST A DRAEGER MEDICAL UPDATE KIT. SEND THE FRAME OF FORMER PRINTED CIRCUITS (PCB) TO DRAEGER MEDICAL BY MAIL IN THE ADDRESS AFFECTED. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (2) IF THERE IS NO TIME AVAILABLE FOR EXCHANGE OF THE PCB, THE COMPLETE ELECTRONIC CONTROL MODULE CAN BE REMOVED AND SHIPPED TO DRAEGERSERVICE. DRAEGER MEDICAL DECLARES THAT IT WILL MAKE A COMPLETE PCB EXCHANGE AND A FREE PREVENTIVE MAINTENANCE. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (3) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT DOES NOT HAVE AN AUTHORIZED DRAEGER MEDICAL TECHNICIAN OR HAS NO TIME TO PERFORM OPTIONS 1 AND 2, DRAEGER MEDICAL DECLARES THAT A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SERVICE WILL MAKE THE UPDATE ON THE SITE. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO RH600 HEATER UPGRADE OPTIONS: (1) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT MAY PARTICIPATE IN THE UPDATE, DRAEGER MEDICAL AFFIRMS THAT THE HEATER MUST BE SUBMITTED FOR PROPER CHANGE. THE HEATER WILL BE RETURNED UPDATED AND WITH FREE PREVENTIVE MAINTENANCE WITHIN THE 2 DAYS USEFUL DEADLINE. THE BIOMEDICAL ENGINEERING PERSONNEL MAY THEN REINSTALL THE HEATER AND FILL IN THE FEEDBACK FORM. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. (2) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT CAN NOT PARTICIPATE IN THE UPDATE, SEND THE HEATER TO DRAEGER MEDICAL, WHICH WILL MAKE A COMPLETE UPDATE. A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SUPPORT SERVICE WILL VISIT YOUR HOSPITAL TO INSTALL THE UPDATED HEATER. PREVENTIVE MAINTENANCE WILL BE MADE FREE OF CHARGE. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. FILL IN AND SEND THE CONFIRMATION RESPONSE CARD TO THE MEDICAL DRAEGER BY MAIL AT THE ADDRESS AFFECTED. FOR FURTHER INFORMATION REGARDING CORRECTION CORRESPONDENCE, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH JAMES BRENNAN, DRAEGER MEDICAL, BY MAIL AT THE ADDRESS OR AT TELEPHONE 1 (215) 721-5400, RAMAL 2363, IN THE UNITED STATES. FOR FURTHER INFORMATION REGARDING THE USE OF THE AFFECTED PRODUCTS, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH HARALD KNEUER, DRAEGERSERVICE, TELEPHONE 1 (215) 721-5400 RAMAL 6917, IN THE UNITED STATES.