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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL X3

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SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL X3 Back to Search Results
Model Number VERSACELL X3
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2021
Event Type  Malfunction  
Manufacturer Narrative

The customer contacted the siemens customer care center (ccc). Siemens noted that there was evidence of poor barcode labels. A customer service engineer (cse) was dispatched to the customer site to perform troubleshooting. The cse observed that a sample tube was picked up low on the tube and drop inside the system. The cse performed the following services and monitored the system's performance: replaced the f/o (fiber optics), r axis motor and gearbox, wrist assembly, and x-axis tg (tragentory generator). The system was verified and performed with no errors post-service repairs. Siemens reviewed the information provided, and the service performed and concluded that the x-axis tg replacement resolved the issue. The customer is satisfied with the service performed. The system was verified and operating as intended. No further evaluation of the device was required. Mdr 2247117-2021-00009 was filed for the same event.

 
Event Description

The customer informed siemens that the versacell x3 system dropped sample tubes. The customer reported that sample tubes were dropped inside the system and contaminated samples in the rack. There are no known reports of adverse health consequences due to the dropped sample tubes.

 
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Brand NameVERSACELL X3
Type of DeviceVERSACELL X3
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
62 flanders bartley rd
flanders NJ 07836
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
62 flanders bartley rd
registration #: 2247117
flanders NJ 07836
Manufacturer Contact
rolando hualpa
511 benedict avenue
tarrytown, NY 10591
9145242963
MDR Report Key11529703
MDR Text Key268559890
Report Number2247117-2021-00010
Device Sequence Number1
Product Code DGC
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK970227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/19/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVERSACELL X3
Device Catalogue Number10793839
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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