MAUDE Adverse Event Report: ARCOMA AB RADPRO OMNERA 400T; 0180 INTUITION AND 0072 PRECISION STATIONARY DIGITAL X-RAY SYSTEMS

Model Number	0180
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incorrect installation.The installer did not follow the instructions and lifted the table without transportation clamp mounted.The table top fell down.No person was injured.Since this is the second time (happened once in 2015 for an oem customer) we consider this as a foreseeable misuse.As an immediate action the tables will be delivered with a warning sign inside the crate.We will change the design in order for the table to withstand this type of incorrect handling.Design change will be fully implemented in february 2018.Already installed tables are safe to use.No field action is required.
Event or Problem Description
Happened during installation.The installer did not follow the instruction and lifted the table without the safety clamp mounted.The table top fell down.No person was injured.

• Brand Name: RADPRO OMNERA 400T
• Common Device Name: 0180 INTUITION AND 0072 PRECISION STATIONARY DIGITAL X-RAY SYSTEMS
• Manufacturer (Section D): ARCOMA AB; annavägen1; växjö, 35246 ; SW 35246
• MDR Report Key: 7139207
• Report Number: 9616014-2017-00003
• Device Sequence Number: 1290480
• Product Code: KPR
• UDI-Device Identifier: 07350008750050
• UDI-Public: 07350008750050
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Service Personnel
• Device Model Number: 0180
• Device Catalogue Number: 0180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1