Device product
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Z-0971-2024
Product summary
- Event
- Event 93544
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 imported to US, not distributed to end users
- Official record key
device-enforcement:Z-0971-2024
Official wording
Reason: Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.
Code information: UDI-DI: 04048675556176 (Atlan A350) 04048675556183 (Atlan A350 XL) Lots: ASSH-0220 ASSH-0221 ASSH-0222 ASSH-0223 ASSH-0224 ASSH-0225 ASSH-0226 ASSH-0227 ASSH-0228 ASSH-0229 ASSH-0230 ASSH-0231 ASSH-0232 ASSH-0233 ASSH-0234 ASSH-0235 ASSH-0236 ASSH-0237 ASSH-0238 ASSH-0239 ASSH-0240 ASSH-0241 ASSH-0242 ASSH-0243 ASSH-0244 ASSH-0245 ASSH-0246 ASSH-0247 ASSH-0248 ASSH-0249 ASSH-0250 ASSH-0251 ASSH-0252 ASSH-0253 ASSH-0254 ASSL-0347 ASSL-0347 ASSL-0349 ASSL-0350 ASSL-0351 ASSL-0352 ASSL-0353 ASSL-0354 ASSL-0355 ASSL-0356 ASSL-0357 ASSL-0358 ASSL-0359 ASSL-0360 ASSL-0361
Distribution pattern: No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.
Derived failure modes
-
Unknown
Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.