MIDMARK 630-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-13 for MIDMARK 630-001 manufactured by Midmark Corp..

Event Text Entries

[1976371] The neutral and ground prongs fell out of the power inlet where the power cord plugs into the table.
Patient Sequence No: 1, Text Type: D, B5

[9104221] The power inlet showed signs of abuse. The plastic edge at the top of the inlet was broken. It appears that the power cord was unplugged from the inlet by pulling the cord perpendicular to the inlet.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1523530-2011-00008
• MDR Report Key: 2081809
• Report Source: 06
• Date Received: 2011-04-13
• Date of Report: 2011-04-13
• Date of Event: 2011-03-21
• Date Mfgr Received: 2011-03-21
• Device Manufacturer Date: 2006-05-01
• Date Added to Maude: 2011-05-17
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: DONALD CARR
• Manufacturer Street: 60 VISTA DR.
• Manufacturer City: VERSAILLES OH 45380
• Manufacturer Country: US
• Manufacturer Postal: 45380
• Manufacturer Phone: 9375263662
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIDMARK
• Generic Name: CHAIR, SURGICAL, AC-POWERED
• Product Code: GBB
• Date Received: 2011-04-13
• Returned To Mfg: 2011-04-04
• Model Number: 630-001
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIDMARK CORP.
• Manufacturer Address: VERSAILLES OH US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-04-13