U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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Non-AC Powered Patient Lift - Product Code FSA
원인
The battery pack nda0200-20, lot 070826d, sold with the maxi move patient lift or as replacement parts, has a defective connector that could lead to the inability of the battery pack to recharge and/or short circuit, resulting in smoke emission.
조치
Arjo sent the Urgent Device Recall Customer Notification dated 11/5/08 and Field Safety Notice (FSN) dated 10/31/08 to all affected Maxi Move customers on 11/5/08. The accounts were informed of the problem with the connector of the battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift (model numbers starting with KMC)or as replacement parts. They instructed the accounts to discontinue use of the battery pack if it does not recharge or has an intermittent electrical contact. The accounts were requested to complete and return to Arjo Inc., the enclosed customer response form indicating that they have received the notification package. The accounts will be contacted by an Arjo representative within a week to arrange the replacement of the battery pack and corresponding connectors (male part/plug) on the lift and battery charger.
lot number 070826D; This battery pack was solely supplied with Maxi Move floor lift model numbers starting with KMCxxx or sold separately as replacement parts.
Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada J1X 5Y5 || The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.