INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500 (2015-07-31)

Starting date:

July 31, 2015

Posting date:

August 10, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-54530

• 
  Reason
• 
  Affected products

Affected Products

A. INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500

Reason

Draeger became aware about an event in which the battery capacity of the optional PS500 of an IACS workstation critical care (Evita Infinity V500) did not last as long as expected. The batteries installed in the PS500 depleted much earlier than expected although the battery indicator showed a sufficiently charged battery. The sequential alarms "battery low" followed by "batter depleted" were given, however, the remaining time until the ventilator shut down was not foreseeable. When the battery depleted totally, the power fail alarm was generated. Draeger issued a measure in February 2014 and July 2014 regarding battery capacity failures. The root cause for the reduced battery capacity at that time was due to an incorrect charging algorithm that subsequently caused Sulfation within the battery. The new battery that was exchanged with that corrective action was tested and qualified. However, Draeger has learned from the supplier that the batteries of this lot may be affected by a manufacturing defect that may lead to shorter battery life times. As a consequence, Draeger has decided to replace all batteries for the ps500 again

Affected products