A-Series (A5/A7) Anesthesia Delivery System

Starting date:

July 14, 2017

Posting date:

September 5, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-64346

• Reason
• Affected products

Reason

Mindray has become aware of the potential for a software anomaly to manifest on the a-series anesthesia system. No adverse patient event was reported. This potential issue is related to the system's electrically erasable programmable read-only memory (EEPROM) and will only occur if the system's total number of write cycles to a particular range of memory locations has exceeded the life specification of the EEPROM. The issue will only manifest at start up or at the end of a case. It will not occur during a case. Two scenarios may occur resulting from this issue.

1) The unit will not be able to enter standby mode when the user confirms "discharge" (in software bundle version < 02.06.00) or "end case" (in software bundle version > 02.06.00) in the dialog box. Under these conditions, the unit can only enter the standby mode by manually unchecking "restore default settings" in the same dialog box. When the "restore default settings" in the dialog box is unchecked, the previous settings will be applied to the next case instead of the user established default settings. If left unaddressed for a period of time, this second scenario will be encountered.

2) At startup the unit will automatically skip over the startup leak test, as well as standby mode and immediately enter either manual or automatic ventilation mode depending on the position of the manual/auto switch. This potential issue affects A-series systems with software bundle version 02.02.00 through 02.11.00 and some units with 02.11.01.

Affected products