MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY

Model Number GAB1000-01-EU

Device Problems Use of Device Problem (1670); Device Tipped Over (2589); Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848); Swelling (2091)

Event Date 03/13/2014

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh representative that during docking from entroy arm to the chair the handle has been pulled out before docking was completed and the seat was not in the right position.When the caretaker started to move the patient, the seat tipped and the patient fell to the floor.From the received information injury to the patient occurred: swelling forehead, bruise on knee and redness on inner elbow.Reference mfr report 9611530-2014-00027.

• Brand Name: ENTROY
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• MDR Report Key: 3832478
• MDR Text Key: 4453929
• Report Number: 1419652-2014-00107
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GAB1000-01-EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2014
• Distributor Facility Aware Date: 03/18/2014
• Event Location: Other
• Date Report to Manufacturer: 04/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 80