MIDMARK 622-008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-02-05 for MIDMARK 622-008 manufactured by Midmark Corp..

Event Text Entries

[3355629] The facility reported the table collapsed the final 5 inches of operation while a pt was on the table. No injury to the pt occurred.
Patient Sequence No: 1, Text Type: D, B5

[10564917] An independent svc company was sent to evaluate the device. The device was evaluated and no root cause was found for the described event. The svc provider performed test to ensure that the function was as intended.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1523530-2013-00003
• MDR Report Key: 2985954
• Report Source: 00
• Date Received: 2013-02-05
• Date of Report: 2013-02-07
• Date of Event: 2013-01-08
• Date Mfgr Received: 2013-01-08
• Device Manufacturer Date: 2010-09-01
• Date Added to Maude: 2013-04-19
• 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: CRAIG RAMMEL
• Manufacturer Street: 60 VISTA DR.
• Manufacturer City: VERSAILLES OH 45380
• Manufacturer Country: US
• Manufacturer Postal: 45380
• Manufacturer Phone: 9375268249
• Single Use: 3
• Remedial Action: IN
• 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: 2013-02-05
• Model Number: 622-008
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIDMARK CORP.
• Manufacturer Address: VERSAILLES OH US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-02-05