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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH UROSKOP OMNIA MAX STATIONARY X-RAY SYSTEM

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SIEMENS HEALTHCARE GMBH UROSKOP OMNIA MAX STATIONARY X-RAY SYSTEM Back to Search Results
Model Number 10762473
Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2019
Event Type  malfunction  
Manufacturer Narrative
The monitor support arm is an independent component purchased by siemens from a 3rd party supplier. It is delivered as a part of the whole system. Initial analysis performed at the supplier showed emerging safety element, which is placed between swivel arm and height adjustable carrying arm of the monitor support stand. The safety element serves as a preventive mechanism from dislodging of carrying arm and swivel arm from each other. Emergence of the safety element is first indication that it is undergoing increased wear. In cooperation with the supplier siemens is conducting a thorough investigation to determine the exact root cause. Siemens will be informing all potentially affected users of this issue and issue a corrective action to inspect affected systems replace parts if needed.
 
Event Description
During an on-site visit siemens local service engineer noticed an issue with the uroskop omnia max unit. The gap between carrying arm and swivel arm was not according to specifications. Respective actions to prevent the arms from dislodging have been taken. There is no patient involvement in this event. No injuries are attributed to this incident.
 
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Brand NameUROSKOP OMNIA MAX
Type of DeviceSTATIONARY X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemensstr.1
forchheim, 91301
GM 91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
siemensstr.1
forchheim, 91301
GM 91301
Manufacturer Contact
anastasia sokolova
40 liberty blvd, mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key8541100
MDR Text Key145915871
Report Number3004977335-2019-66062
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10762473
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/23/2019 Patient Sequence Number: 1
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