MAUDE Adverse Event Report: BECKMAN COULER WALKAWAY 40 PLUS; INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS

Model Number N/A

Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

It was reported that the spring from the panel access door hinge "popped" out and landed on the counter when the user was accessing the walkaway instrument.The exact date of event was unknown however it was reported that it occurred several months ago.It was reported that the user was not wearing safety glasses for eye protection other than regular glasses.There was no report of injury due to this incident.

Manufacturer Narrative

A field action was issued on june 2014 for this type of failure and filed with the fda per report number z-1990-2014.(b)(4).

• Brand Name: WALKAWAY 40 PLUS
• Type of Device: INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS
• Manufacturer (Section D): BECKMAN COULER; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer (Section G): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer Contact: norma rahill ; 1584 enterprise blvd; west sacramento, CA 95691 ; 9163742139
• MDR Report Key: 4813353
• MDR Text Key: 5833012
• Report Number: 2919016-2015-00073
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: N/A
• Device Catalogue Number: B1018-283
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1990-2014
• Patient Sequence Number: 1