MAUDE Adverse Event Report: BECKMAN COULTER WALKAWAY 96 PLUS; INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS

Model Number N/A

Device Problems Break (1069); Device Emits Odor (1425); Failure to Power Up (1476); Smoking (1585); Electrical Shorting (2926)

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

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

The walkaway plus not powering up was likely due to the incorrect wiring of the originally installed power adapter.The original power adapter has been requested for return to the manufacturer for further evaluation.The electrical short was likely a result of using the power adapter from a different instrument model from the manufacturer.Review of the photo submitted revealed that the orange and blue power cables (primary line of the transformer) in the instrument were burnt.(b)(4).

Event Description

It was reported that the walkaway plus instrument would not power up during installation.The manufacturer field service engineer replaced the power adapter from a different instrument model from the manufacturer.When the walkaway plus instrument was powered up, smoke and burning smell was observed.An electrical short occurred damaging the cables of the instrument.

Manufacturer Narrative

The power adaptor was returned for investigation.The investigation revealed it does not match the manufacturer's drawing specification.It is possible the part was assembled and/or wired incorrectly.A new walkaway plus instrument was delivered to the customer.(b)(6).

• Brand Name: WALKAWAY 96 PLUS
• Type of Device: INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS
• Manufacturer (Section D): BECKMAN COULTER; 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: 4937443
• MDR Text Key: 22953313
• Report Number: 2919016-2015-00097
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Service and Testing Personnel
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: N/A
• Device Catalogue Number: B1018-284
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1