Device product

SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

Z-1442-2014

March 10, 2014

Class I

Product summary

Firm: Del Mar Reynolds Medical, Ltd.
Event: Event 67781
Status: Terminated
Classification: Class I
Quantity: 16 units distributed in the US
Official record key: device-enforcement:Z-1442-2014

Official wording

Reason: The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.

Code information: SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.

Distribution pattern: USA Nationwide Distribution in the states of North Carolina and South Carolina

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.