MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. VOYAGER 420

Device Problem Material Separation (1562)

Patient Problems Contusion (1787); Pain (1994)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

The client fell from the pt lift to the toilet.The pt lift strap was completely ruptured.The client sustained back contusions and pain to buttocks.

• Brand Name: VOYAGER 420
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay st.; magog, quebec ; CA
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3723698
• MDR Text Key: 4305606
• Report Number: 1419652-2014-00007
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2014
• Distributor Facility Aware Date: 12/20/2013
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 64