MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY

Model Number GAB1011-01-GB

Device Problem Device Tipped Over (2589)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that after transferring the patient out of the pool area onto the chair, the staff member maneuvered the chair into the showering area where at this point, the chair tipped or collapsed, and the patient landed on the floor and bruised his left side.On (b)(6) 2014, user facility confirmed that device tipped, not collapsed: "i was not the individual using the hoist when it tipped, it was my colleague (.).I have trained her this year in the use of the hoist".

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjo hospital equipment ab on behalf of the importer arjohuntleigh, inc ((b)(4)).Additional information will be provided upon completion of the investigation.(b)(4).

• Brand Name: ENTROY
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5,; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12635 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4239863
• MDR Text Key: 21724034
• Report Number: 9611530-2014-00085
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GAB1011-01-GB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2014
• Distributor Facility Aware Date: 10/01/2014
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2014
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other