* HLT4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-28 for * HLT4 manufactured by Djo Inc..

Event Text Entries

[1587850] Patient was in the supine position with the patient's upper body placed on the foot of the treatment table. The patient's lower body was positioned over the head of the treatment table which was elevated. The therapist was performing manual hamstring stretch when the head of the table went flat. The patient did not sustain any injuries. The patient was assisted up and was escorted to another room where the therapy was completed. Upon inspection by biomedical services, the leg section was found off-track. The guide wheels located at the head of the bed was found off-track and chipped. ====================== health professional's impression======================unknown====================== manufacturer response for treatment table, (brand not provided)======================henley international merged with chattanooga group who merged with djo. All divisions were contacted and none will claim support for the unit. The unit was removed from service and is currently in storage.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1807864
• MDR Report Key: 1807864
• Date Received: 2010-07-28
• Date of Report: 2010-07-28
• Date of Event: 2010-06-24
• Report Date: 2010-07-28
• Date Reported to FDA: 2010-07-28
• Date Added to Maude: 2010-08-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: TREATMENT TABLE
• Product Code: INW
• Date Received: 2010-07-28
• Model Number: HLT4
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Age: 14 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DJO INC.
• Manufacturer Address: 1430 DECISION STREET VISTA CA 92081 US 92081

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-07-28