Invia Motion Negative Pressure Wound Therapy (NPWT) System (2018-06-05)

Starting date:

June 5, 2018

Posting date:

July 5, 2018

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-67170

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  Reason
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  Affected products

Affected products

Invia Motion Negative Pressure Wound Therapy (NPWT) System

Reason

Medela AG identified an issue where the unforeseen user battery charging behaviour has led to a malfunction. This malfunction was identified only in the case where the user repeatedly plugged and unplugged the pump to the power source and the battery was fully charged. Technically, this can cause the safety fuse to temporarily open the battery connection. When this situation occurs, the device no longer recognises the presence of the battery and notifies the user with a visual and audible "battery missing" notification. In case the device is unplugged in this situation, this will cease operation of the device.

Affected products