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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGFA N.V. DX-D600 - DXD IMAGING PACKAGE; DX-D 600 SYSTEM

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AGFA N.V. DX-D600 - DXD IMAGING PACKAGE; DX-D 600 SYSTEM Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2018
Event Type  malfunction  
Manufacturer Narrative
Agfa healthcare nv has recently changed the company structure into two legal entities, named agfa healthcare and agfa nv.This report is for agfa n.V.Agfa n.V's owner operator number is (b)(4).Agfa n.V.Is currently awaiting the assignment of a fda registration number.This report has been submitted via the manufacturer registration number (b)(4) for agfa healtcare n.V.
 
Event Description
A customer in (b)(6) reported to agfa, while using the dx-d 600 system, they experienced fast downward movement of the tube.The customer reported when the omni-button was pressed, the dx-d 600 system tube moved downward in a fast motion.When the omni-button was released, this immediately stopped the downward fast motion.Agfa service responded and checked the system.Agfa service tested the gas springs and the tension was ok.The balancing was readjusted in the gauge board and the compensation was adjusted.The system was calibrated and tested ok.The root cause is determined to be drifting of the gauge board balancing calibration.The unit is now working as intended and no further incidents have been reported.There has been no reported harm to patient or user during these events.
 
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Brand Name
DX-D600 - DXD IMAGING PACKAGE
Type of Device
DX-D 600 SYSTEM
Manufacturer (Section D)
AGFA N.V.
septestraat 27
mortsel, B 264 0
BE  B 2640
Manufacturer (Section G)
AGFA N.V.
septestraat 27
mortsel, B 264 0
BE   B 2640
Manufacturer Contact
cassandra mcgowan
10 s academy street
greenville, SC 29601
8644211984
MDR Report Key8245542
MDR Text Key133319030
Report Number9616389-2019-00004
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K112670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/14/2019
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? Yes
Initial Date Manufacturer Received 12/20/2018
Initial Date FDA Received01/14/2019
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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