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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARCOMA AB PANORAD; PANORAD X-RAY SYSTEM
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ARCOMA AB PANORAD; PANORAD X-RAY SYSTEM Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
Rca still under investigation.The problem could not be recreated.Controlboard is exchanged.The old board is sent to us for further investigation.
 
Event Description
Uncontrolled movement of the u-arm.A bilateral knee examination (right knee) has been performed on a lying patient with near vertical beam direction (5 °), the detector underneath the table.The u-arm has then been lowered and positioned for a sunrise or skyline examination where the tube is tilted about 20 ° to get a picture of the knee bowl.The user has released the button at the desired position, but the u-arm continued to rotate until it stopped in position for a horizontal beam targeting.The table with the patient was pulled upwards and the users who was focused on the patient did not activate the emergency stop.No one was injured.
 
Manufacturer Narrative
The problem could not be recreated.The control board has been analysed by original manufacturer, syfm co., ltd (shin young for m).No failure detected, the control board works as intended within specifications.User error can not be ruled out.The device is consider safe, the user manual clearly states on the first page the importance of trained personnel, how to operate the device and that the emergency stop should be used.
 
Event Description
Uncontrolled movement of the u-arm.A bilateral knee examination (right knee) has been performed on a lying patient with near vertical beam direction (5 °), the detector underneath the table.The u-arm has then been lowered and positioned for a sunrise or skyline examination where the tube is tilted about 20 ° to get a picture of the knee bowl.The user has released the button at the desired position, but the u-arm continued to rotate until it stopped in position for a horizontal beam targeting.The table with the patient was pulled upwards and the users who was focused on the patient did not activate the emergency stop.No one was injured.
 
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Brand Name
PANORAD
Type of Device
PANORAD X-RAY SYSTEM
Manufacturer (Section D)
ARCOMA AB
annavägen 1
växjö, 35246
SW  35246
MDR Report Key7233412
MDR Text Key98763283
Report Number9616014-2018-00001
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
PMA/PMN Number
K113855
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/09/2018
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
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/11/2018
Initial Date FDA Received02/01/2018
Supplement Dates Manufacturer Received01/11/2018
Supplement Dates FDA Received04/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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