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 04/24/2014

Event Type  malfunction  

Event Description

During a service visit, the customer expressed that something was wrong with the walkaway 96 plus instrument access door.The field service technician opened the door and found out that the top hinge pin of the door was disengaged from the hinge assembly, and the other end appeared to be bent.

• Brand Name: WALKAWAY 96 PLUS
• Type of Device: WALKAWAY 96 PLUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; west sacramento CA 95691
• Manufacturer Contact: jose untalan ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9163743031
• MDR Report Key: 3902530
• MDR Text Key: 19799009
• Report Number: 2919016-2014-00022
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/24/2014

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: Other
• Device Catalogue Number: B1018-284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1