PHYSICAL THERAPY EXAM TABLE 2000E *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-02 for PHYSICAL THERAPY EXAM TABLE 2000E * manufactured by Laberne Manufacturing Company.

Event Text Entries

[594177] Physical therapy was initiating pt treatment on the tilt table. The tilt table was plugged into the outlet. The tilt table's up and down motion was tested and no problems noted. Physical therapy staff transferred the pt from her bed to the tilt table. When the pt reached the tilt table, a loud "pop" was heard. Physical therapy sighted and smelled the smoke. The tilt table was unplugged, flames were seen between the tilt table and the pt's bed. The pt's daughter put a blanket over the flame to smother it while the staff protected the pt's body from the fire. The fire was put out quickly. The pt was transferred back to her bed -the only damage to the pt's bed was the siderail was burnt. The pt was assessed and found to be unharmed. The pt denied any injuries when asked. The tilt table was removed from the room.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1041826
• MDR Report Key: 811868
• Date Received: 2007-02-02
• Date of Report: 2007-02-02
• Date of Event: 2007-01-18
• Date Added to Maude: 2007-02-06
• 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: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PHYSICAL THERAPY EXAM TABLE
• Generic Name: TILT TABLE
• Product Code: JFB
• Date Received: 2007-02-02
• Model Number: 2000E
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 799351
• Manufacturer: LABERNE MANUFACTURING COMPANY
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2007-02-02