RITTER 222-016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-09-04 for RITTER 222-016 manufactured by Midmark Corp..

Event Text Entries

[3881775] Facility claims table unintentionally moved while a pt was on the table. No injuries occurred.
Patient Sequence No: 1, Text Type: D, B5

[11157703] The product is not being returned for further eval. Product was evaluated on site by service provider. They could not find issue with the product. No damage to the unit was found. Function testing was performed to ensure operation of up/down features. No misalignment was found.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1523530-2013-00015
• MDR Report Key: 3415916
• Report Source: 06,07
• Date Received: 2013-09-04
• Date of Report: 2013-08-30
• Date of Event: 2013-08-01
• Device Manufacturer Date: 2012-03-01
• Date Added to Maude: 2013-12-03
• 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: 9375263662
• Single Use: 3
• Remedial Action: RP
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RITTER
• Generic Name: EXAMINATION TABLE
• Product Code: LGX
• Date Received: 2013-09-04
• Model Number: 222-016
• 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		2013-09-04