96701

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-02 for 96701 manufactured by American Echo, Inc, Now Medical Positioning.

Event Text Entries

[17528288] Patient sitting on the side of tilt table. Patient using hands to brace self in sitting position. Tilt table foot rest fell onto patient's right wrist. Found no defect in the table, nothing broken or out of place. The footboard is simply free to fold up when the table is in the prone position. Contacted manufacturer to inquire if there was a retrofit or some way to prevent this from occurring again. Told the only thing that could be done to stop the drop of the foot board was to tight the allen screws where the foot board pivots until there was enough drag to keep it from falling. There was no other locking mechanism available from them.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5011293
• MDR Report Key: 1399132
• Date Received: 2009-06-02
• Date of Report: 2009-06-02
• Date of Event: 2009-04-09
• Date Added to Maude: 2009-06-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Generic Name: TILT TABLE
• Product Code: JFB
• Date Received: 2009-06-02
• Model Number: 96701
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN ECHO, INC, NOW MEDICAL POSITIONING
• Manufacturer Address: 1717 WASHINGTON ST KANSAS CITY MO 64108 US 64108

Device Sequence Number: 2

• Generic Name: TILT TABLE
• Product Code: JFB
• Date Received: 2009-06-02
• Model Number: 96701
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: AMERICAN ECHO, INC, NOW MEDICAL POSITIONING
• Manufacturer Address: 1717 WASHINGTON ST KANSAS CITY MO 64108 US 64108

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-06-02