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

Model Number ADVIA CENTAUR XP

Device Problem Mechanical Problem (1384)

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

Event Date 06/29/2015

Event Type  malfunction  

Event Description

The customer contacted the siemens customer care center and stated that the lid of the advia centaur xp instrument would not stay open and had fallen onto operators, hitting their heads.No medical intervention or treatment was required.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse discovered that the gas spring had failed and the instrument cover was damaged.The cse replaced the gas spring and the top window and verified that the instrument was operational.The cause of the instrument cover falling onto the operators was a malfunction of the gas spring.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 jul.2, 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 4888555
• MDR Text Key: 6264647
• Report Number: 2432235-2015-00315
• 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: 12/12/2017

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 CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 12/12/2017
• 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