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Recall Observatory FDA recall evidence

Device product

DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.

Z-0837-2015

October 06, 2014

Class II

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 69788
Status
Terminated
Classification
Class II
Quantity
455 units
Official record key
device-enforcement:Z-0837-2015

Official wording

Reason: Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.

Code information: DPM 6 - PN: C-047-000199-00 and DPM 7 - PN: C-047-000200-00, IBP Module P/N: 6800-30-50485

Distribution pattern: Distributed to the states of AL, CA, CO, FL, GA, IA, IL, IN, LA. MA, MO, MS, MT, NC, ND, NY, OH, PA, SC, TX, VA, WA and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.