MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 01/16/2014

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh representative that the caregiver was lowering tub, it stopped and suddenly dropped onto caregivers right toes.Reference mfr# 9611530-2014-00009.

• Brand Name: SYSTEM 2000
• 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: 3764924
• MDR Text Key: 4549630
• Report Number: 1419652-2014-00030
• Device Sequence Number: 1
• Product Code: ILM
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2014
• Distributor Facility Aware Date: 01/16/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR