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

Model Number 0180

Device Problem Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2017

Event Type  malfunction  

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 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
• Type of Device: 0180 INTUITION AND 0072 PRECISION STATIONARY DIGITAL X-RAY SYSTEMS
• Manufacturer (Section D): ARCOMA AB; annavägen1; växjö, 35246 ; SW 35246
• Manufacturer (Section G): ARCOMA AB; annavägen 1; växjö, 35246 ; SW 35246
• Manufacturer Contact: elisabeth lundahl ; annavägen1; växjö, 35246 ; SW 35246
• MDR Report Key: 7139207
• MDR Text Key: 96043892
• Report Number: 9616014-2017-00003
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 07350008750050
• UDI-Public: 07350008750050
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: 0180
• Device Catalogue Number: 0180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1