Device product
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
Z-1642-2018
Product summary
- Event
- Event 79811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units (1 US, 13 International)
- Official record key
device-enforcement:Z-1642-2018
Official wording
Reason: There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
Code information: US: 98880-020 Foreign: 98880 - 002, 98880 - 004, 98880 - 005, 98880 - 006, 98880-009, 98880-010, 98880-011, 98880-012, 98880- 013, 98880-014, 98880-016, 98880-017, 98880-018
Distribution pattern: The product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
Derived failure modes
-
Unknown
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.