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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 097 05 18 001
Date submitted: 6/27/2018
Manufacturer:Draeger Medical Systems Inc.
Device Type:Fabius, Apollo & Perseus devices
Description:Anesthesia Units
Medical Device Identifier:Dräger Fabius, Apollo & Perseus devices with S-ORC

Serial Numbers: ASKM-0203 and ASKM-0197

.................................................

FDA update codes:
Perseus A500 Anesthesia Machine; Cat. no. MK06000
Codes: ASKM-0197 ASKN-0006 ASKN-0007 ASKN-0008 ASKN-0009 ASKN-0013 ASKN-0014 ASKN-0015 ASKN-0021 ASKN-0026 ASKN-0027 ASKN-0028 ASKN-0029 ASKN-0030 ASKN-0031 ASKN-0034 ASKN-0035 ASKN-0036 ASKN-0037 ASKN-0038 ASKN-0039 ASKN-0040 ASKN-0042 ASKN-0045 ASKN-0046 ASKN-0048 ASKN-0049 ASKN-0050 ASKN-0053 ASKN-0054 ASKN-0055 ASLA-0009 ASLA-0010

Apollo Anesthesia Machine; Cat. no. 8605310
Codes: ASKM-0152 ASKN-0138 ASKM-0193 ASKN-0139 ASKM-0202 ASKN-0143 ASKM-0203 ASKN-0144 ASKM-0211 ASKN-0148 ASKM-0212 ASKN-0150 ASKM-0213 ASKN-0151 ASKM-0214 ASKN-0152 ASKM-0221 ASKN-0163 ASKM-0222 ASKN-0164 ASKM-0227 ASKN-0165 ASKM-0228 ASLA-0001 ASKM-0246 ASLA-0002 ASKM-0269 ASLA-0003 ASKM-0272 ASLA-0092 ASKM-0328 ASLA-0121 ASKM-0332 ASLA-0124 ASKM-0333 ASLA-0131 ASKM-0337 ASLA-0132 ASKM-0339 ASLA-0145 ASKM-0340 ASLA-0146 ASKM-0360 ASLA-0152 ASKM-0362 ASLA-0153 ASKM-0366 ASLA-0154 ASKM-0370 ASLA-0163 ASKM-0371 ASLA-0164 ASKM-0408 ASLA-0165 ASKM-0409 ASLA-0166 ASKM-0415 ASLA-0173 ASKN-0012 ASLA-0174 ASKN-0035 ASLA-0175 ASKN-0039 ASLA-0179 ASKN-0040 ASLA-0180 ASKN-0113 ASLA-0181 ASKN-0114 ASLA-0182 ASKN-0116 ASLA-0183

Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000
Codes: ASKM-0110 ASKM-0111 ASKM-0196 ASKM-0209 ASKM-0232 ASKM-0244 ASKM-0246 ASKN-0032 ASKN-0033 ASKN-0034 ASKN-0037 ASKN-0041 ASKN-0043 ASKN-0068 ASKN-0093 ASLA-0009 ASLA-0021 ASLA-0023 ASLA-0031 ASLA-0032 ASLA-0123 ASLA-0130 ASLA-0135 ASLA-0136 ASLA-0147 ASLA-0155 ASLA-0158 ASLA-0163 ASLA-0166 ASLA-0170 ASLA-0195

Fabius GS MRI Anesthesia Machine; Cat. no. 8607300
Codes: ASLA-0017 ASLA-0018 ASLA-0019 ASLA-0020

Fabius GS Premium Anesthesia Machine; Cat. no. 8607000
Codes: ASKM-0102 ASKM-0220 ASKM-0103 ASKM-0221 ASKM-0124 ASKM-0222 ASKM-0125 ASKM-0223 ASKM-0129 ASKM-0224 ASKM-0132 ASKM-0229 ASKM-0133 ASKN-0061 ASKM-0134 ASKN-0090 ASKM-0135 ASLA-0035 ASKM-0136 ASLA-0046 ASKM-0137 ASLA-0047 ASKM-0138 ASLA-0048 ASKM-0139 ASLA-0049 ASKM-0189 ASLA-0050 ASKM-0190 ASLA-0053 ASKM-0191 ASLA-0070 ASKM-0192 ASLA-0071 ASKM-0193 ASLA-0072 ASKM-0194 ASLA-0073 ASKM-0195 ASLA-0074 ASKM-0198 ASLA-0075 ASKM-0199 ASLA-0129 ASKM-0200 ASLA-0131 ASKM-0201 ASLA-0133 ASKM-0202 ASLA-0140 ASKM-0204 ASLA-0141 ASKM-0205 ASLA-0159 ASKM-0207 ASLA-0199 ASKM-0208 ASLA-0200 ASKM-0215 ASLA-0201 ASKM-0219 ASLA-0218
Reason of Field Safety Corrective Action:Draeger became aware of a device where it was possible to dose 100% N2O. To date, Draeger are not aware of any reports of this occurring in devices currently in distribution.The above-mentioned anesthesia machines are equipped with a mechanical O2 minimum dosage module (S-ORC). This safety feature prevents the user from inadvertently setting hypoxic gas mixtures (with less than 21% oxygen) at the fresh gas mixer when N2O is selected as one of the carrier gases. Draeger investigation determined that the root cause was a burr not being removed from an internal component of the S-ORC during the production process.
Remedy Action:Draeger will replace S-ORCs for all customers.
Athorized Representative/Importer/Distributor:Draeger Arabia Co. Ltd.
Report Source:NCMDR, FDA
Source Ref. Number:10A370E75F269, Z-2254-2018, Z-2251-2018, Z-2252-2018, Z-2253-2018, Z-2250-2018
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments