MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. VERSACELL SAMPLE MANAGEMENT SYSTEM; GENERAL PURPOSE LABORATORY EQUIPMENT

Model Number VERSACELL SAMPLE MANAGEMENT SYSTEM

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

The operator of a versacell sample management system was performing routine work when the top cover of the analyzer fell down and came in contact with his head.The operator of the versacell sample management system did not require medical intervention, or require any medical treatment.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluating the instrument, the cse determined the gas shocks were not maintaining the top cover in the upright position.The cause of the top cover coming into contact with the operators head is due to a malfunction of the gas shocks.The cse replaced the top cover gas shocks and checked the top cover functionality.The versacell sample management system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Type of Device: GENERAL PURPOSE LABORATORY EQUIPMENT
• 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; flanders NJ 07836
• Manufacturer Contact: john nelson ; siemens healthcare diagnostics; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 4533357
• MDR Text Key: 5545315
• Report Number: 2247117-2015-00007
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/28/2015

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: VERSACELL SAMPLE MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/22/2015
• 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
• Patient Sequence Number: 1