MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problem Component Falling (1105)

Patient Problems Head Injury (1879); Concussion (2192)

Event Date 01/20/2015

Event Type  malfunction  

Event Description

The operator of an advia centaur xp instrument was troubleshooting an issue on the phone with a siemens customer care center specialist when the instrument cover fell onto the operator, hitting their head.The operator went to an emergency room after the instrument cover fell onto them and was diagnosed with a concussion.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse checked the gas spring and shock and did not find a malfunction.There were no visible leaks in the gas spring and all connections were tight and none were damaged.An operator stated that they had raised and lowered lids without issue since the incident.The cause of the instrument cover falling onto the operator is unknown.This instrument is performing according to specifications.No further evaluation of this device is required.Siemens healthcare diagnostics has investigated the occurrences of advia centaur xp instrument covers falling during maintenance procedures.When the instrument cover is raised, the cover is supported by a gas spring attached at the middle of the cover.Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position.This may lead to the cover falling during maintenance procedures.Customers in the united states were sent urgent medical device correction (umdc) 10817522 entitled "advia centaur xp instrument cover gas spring issues" in february 2014.Customers outside of the united states were sent urgent field safety notice (ufsn) 10817521 entitled "advia centaur xp instrument cover gas spring issues" in february 2014.The umdc/ufsn provides guidance to customers by explaining actions to avoid injury and to contact their siemens technical support representative if the cover cannot stay partially raised.Siemens technical support representatives will be routinely inspecting gas springs on regular preventive maintenance cycles or service visits.

Manufacturer Narrative

Initial mdr was filed on february 12, 2015.Additional information (nov.15, 2017): siemens has developed a new gas spring design.Siemens customer service engineers are replacing all gas springs with the new gas spring design during upcoming service visits.On dec.4, 2017, siemens issued a customer notification to customers whose systems have not yet been updated with the new spring design to announce the new gas spring design and remind them that the original gas spring may lose its effectiveness and fail to support the cover in its full or partially open position until their system is updated with the new gas spring design.Customer notification (b)(4) was sent to customers in the us on dec.4, 2017 and customer notification (b)(4) was sent to customers outside the us in december 2017.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane; registration number: 8020888; dublin, swords ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 4512663
• MDR Text Key: 20366264
• Report Number: 2432235-2015-00072
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2432235-02/21/14-003-C
• Patient Sequence Number: 1