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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 Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2020
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 moved up to the ceiling by itself. The patient was not injured.
 
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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 Key12096336
MDR Text Key261916133
Report Number9616014-2021-00004
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 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
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 Manufacturer06/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2019
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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