In the FDA Enforcement Report for the week of November 28, it lists the ongoing recall of the Qube compact monitor (patient monitor) 91390.
The Spacelabs Healthcare Qube compact monitor 91390, functioning as either a bedside or central monitor, passively displays data generated by two Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC-based products in the form of waveform and numeric displays, trends, and alarms.
The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (ie, high, medium, or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the alarm watch feature.
The company recalled the monitors when it learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short.
The Class II recall affects 742 total distributed devices—530 within the US and 212 internationally.
Read more on this recall by clicking here.
