MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS WALKAWAY 96 PLUS

Catalog Number B1018-284

Device Problem Product Quality Problem (1506)

Patient Problem Not Applicable (3189)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

It was reported that the pin that holds the pivot pin on the hinge was intact but the spring was no longer there and likely popped out while the door was closed.The spring was found in the access door area.No damage to the interior of the walkaway plus instrument.No report of adverse event or injury.

Manufacturer Narrative

(b)(4).Product quality issue associated with an inherent device and/or device component characteristic that is not satisfactory as specific or delivered.Siemens healthcare diagnostics inc.Conducted a field correction, internal number (b)(4).A written customer notification was sent on 06/2014 to all customers affected notifying them of the springs contained in the access door hinge assembly on the walkaway plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue fort the customer.The notification also includes actions to be taken by customers.The fda (b)(4) district office was notified on 06/09/2014 of the remedial action (report no.2919016-06/09/14-001-c).Siemens customer service engineer replaced the access door and the walkaway plus instrument is up and running.

• Brand Name: WALKAWAY 96 PLUS
• Type of Device: WALKAWAY 96 PLUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; west sacramento CA
• Manufacturer Contact: jose untalan ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9163743031
• MDR Report Key: 3960837
• MDR Text Key: 4558304
• Report Number: 2919016-2014-00026
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/28/2014

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 Catalogue Number: B1018-284
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2919016-06/09/14-001-C
• Patient Sequence Number: 1