MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TRANSPORT CHAIR

Catalog Number WRX449723

Device Problems Unintended Collision (1429); Device Tipped Over (2589)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 01/07/2014

Event Type  Injury  

Event Description

The end user pushed back while sitting in the transport chair.The chair flipped backwards and she fell, hitting her head.She was subsequently hospitalized.

Manufacturer Narrative

It was reported that the end user pushed back and the chair tipped backward.She hit her head and was subsequently hospitalized.From the info provided, it appears the end user was left unattended while sitting in the chair.The sample was not returned for eval.We have no lot number.The overall condition of the chair is not known.The son acknowledge that there was a warning on the chair not to leave the user unattended.The son declined to provide add'l info and did not respond to phone calls.A root cause has not been confirmed.

• Brand Name: TRANSPORT CHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 3649400
• MDR Text Key: 16686266
• Report Number: 1417592-2014-00013
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: WRX449723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other