Device product

Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

Z-1280-2015

January 23, 2015

Class II

Product summary

Firm: Mindray DS USA, Inc. dba Mindray North America
Event: Event 70546
Status: Terminated
Classification: Class II
Quantity: 519 units
Official record key: device-enforcement:Z-1280-2015

Official wording

Reason: An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement

Code information: 6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293

Distribution pattern: Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement