FDA recall Z-0202-2018

Product

CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

Reason for recall

Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.

Distribution

Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.

Key facts

Status

Terminated

Initiation date

2017-07-13

Report date

2017-12-13

Termination date

2021-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Milwaukee, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0202-2018