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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARCOMA AB OMNERA 400A STATIONARY X-RAY SYSTEM

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ARCOMA AB OMNERA 400A STATIONARY X-RAY SYSTEM Back to Search Results
Model Number 0072
Device Problems Unintended System Motion (1430); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2020
Event Type  malfunction  
Manufacturer Narrative
Please be informed that the reason for this report being late is that we first assessed this problem to be non-reportable.
 
Event Description
The overhead tube crane (otc) has spontaneously started a motorised movement downwards and continued until it collided with the table. No one was in the room. The user heard noise from the room and went back to find the otc standing against the tabletop.
 
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Brand NameOMNERA 400A
Type of DeviceSTATIONARY X-RAY SYSTEM
Manufacturer (Section D)
ARCOMA AB
annavägen 1
växjö, 35246
SW 35246
Manufacturer (Section G)
ARCOMA AB
annavägen 1
växjö, 35246
SW 35246
Manufacturer Contact
katja kristensson
annavägen 1
växjö, 35246
SW   35246
MDR Report Key12073571
MDR Text Key261444380
Report Number9616014-2021-00003
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0072
Device Catalogue Number0072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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