FDA-Device2013-02-20Class II
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
Mindray DS USA, Inc. d.b.a. Mindray North America
Hazard
Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
Sold states
Nationwide Distribution.
Affected count
51 units
Manufactured in
800 MacArthur Blvd., Mahwah, NJ, United States
Products
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0798-2013Don't want to check this manually?
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