Device product
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
Z-0868-2021
Product summary
- Event
- Event 86702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5035
- Official record key
device-enforcement:Z-0868-2021
Official wording
Reason: Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.
Code information: Serial number range 1808090001 to 2006060045
Distribution pattern: Worldwide distribution - US Nationwide distribution.
Derived failure modes
-
Unknown
Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.