TRT 600 SPINE THERAPY TABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-06-14 for TRT 600 SPINE THERAPY TABLE manufactured by Djo Global.

Event Text Entries

[2015747] During a traction treatment, the pt was left unattended and strapped to the table with her young children in the closed treatment room. The (b)(6) child crawled under the table and was trapped under the table. The child subsequently died after being removed. The child was given cpr but died at the hospital. The user manual warnings/cautions clearly state to not leave patients unattended during treatment and to keep children and others away from underneath the treatment table.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1022819-2011-00005
• MDR Report Key: 2129740
• Report Source: 00
• Date Received: 2011-06-14
• Date of Report: 2011-06-14
• Date of Event: 2011-06-10
• Date Added to Maude: 2011-06-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 1430 DECISION STREET
• Manufacturer City: VISTA CA 92081
• Manufacturer Country: US
• Manufacturer Postal: 92081
• Manufacturer Phone: 7607345543
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRT 600 SPINE THERAPY TABLE
• Generic Name: POWERED TRACTION TABLE
• Product Code: INQ
• Date Received: 2011-06-14
• Model Number: TRT 600
• Operator: HEALTH PROFESSIONAL
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DJO GLOBAL
• Manufacturer Address: 1430 DECISION STREET VISTA CA 92081 US 92081

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2011-06-14