MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS WA96 PLUS; WALKAWAY 96 PLUS

Catalog Number B1018-284

Device Problem Product Quality Problem (1506)

Patient Problem Not Applicable (3189)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It was reported that the instrument's access door hinge assembly spring became detached.There was no report of impact to panel results or patient care.

• Brand Name: WA96 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: 3812734
• MDR Text Key: 19762899
• Report Number: 2919016-2014-00018
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1