MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SLINGS, LOOP

Model Number MLA3000-M

Device Problems Break (1069); Use of Device Problem (1670); Human Factors Issue (2948)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2014

Event Type  malfunction  

Event Description

Arjohuntleigh has been aware that sling stitching inside the loop was found damaged, the fault was found before used and no person was involved.Ref mfr #9611530-2014-00012.

• Brand Name: SLINGS, LOOP
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• 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: 3659335
• MDR Text Key: 4196657
• Report Number: 1419652-2014-00040
• Device Sequence Number: 1
• Product Code: IKX
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014,01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MLA3000-M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2014
• Distributor Facility Aware Date: 01/17/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other