Device product
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Z-0419-2018
Product summary
- Event
- Event 78886
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11160
- Official record key
device-enforcement:Z-0419-2018
Official wording
Reason: It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).
Code information: LOT #(s): 1640002, 1645003
Distribution pattern: U.S.
Derived failure modes
-
Unknown
It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).