ATLAS TABLE NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-22 for ATLAS TABLE NI manufactured by Wuestec Medical, Inc..

Event Text Entries

[139486] The headrest (actuator #3) on table was stuck in the "up" position. Svc mgr handled the telephone call and informed user that the possible problem was that they may need a new pcb and they would be sent a replacement. User was issued a rma number and asked to return the pcb in question. User was contacted two add'l times regarding returning the board. On wednesday, 11/29, the pcb was received at mfr's facility. Failure analysis on the pcb began on monday, 12/4/00. Failure analysis investigation revealed that the relay contacts fused together, causing actuator #3 to continue to run until it hit the limit switch, which is a malfunction. Investigation into this problem revealed info, observations and opinions that reasonably suggests that if the device were to malfunction for the same reason again, serious injury or death could result from the malfunction. To elaborate on the consequences fo the malfunction, if actuator #3 continues to run without operator control, the pt's head could run into the stylus if the stylus pin is in a lowered position, which could possibly cause serious injury or death. There was a pt on the table at the time of the malfunction, however, no injury occurred.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002922
• MDR Report Key: 311524
• Date Received: 2000-12-22
• Date of Report: 2000-12-13
• Date of Event: 2000-01-01
• Date Added to Maude: 2001-01-11
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ATLAS TABLE
• Generic Name: TABLE
• Product Code: JFB
• Date Received: 2000-12-22
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 301320
• Manufacturer: WUESTEC MEDICAL, INC.
• Manufacturer Address: 5600 COMMERCE BLVD EAST MOBILE AL 366190037 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-12-22