MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA AUTOSLIDE SYSTEM

Model Number ADVIA AUTOSLIDE SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

The customer contacted siemens healthcare diagnostics inc and stated that he was injured while clearing a rack jam on the advia autoslide instrument.When the customer pulled up the rack cover, he was hit in the tooth with the rack stacker guide.The customer did not need medical attention.There are no known reports of adverse health consequences due to the customer being hit in the tooth by the rack stacker guide.

Manufacturer Narrative

The customer contacted siemens healthcare diagnostics inc.Siemens determined that the cause of the event is due to the user interfacing with the advia autoslide system.The customer did not seek medical attention.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA AUTOSLIDE SYSTEM
• Type of Device: ADVIA AUTOSLIDE SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): ABX, REGISTRATION NUMBER: 3000148879; parc euromedicine; rue du chaducee, bp7290; montpelier, cedex 4, 3418 4; FR 34184
• Manufacturer Contact: elizabeth bernasconi ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242495
• MDR Report Key: 3952935
• MDR Text Key: 19295728
• Report Number: 2432235-2014-00479
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/01/2014

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
• Device Model Number: ADVIA AUTOSLIDE SYSTEM
• Device Catalogue Number: 10282177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1