MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-ST. PAUL) WI-BOX TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number C12783

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Event Description

The quantien was turned on and a guidewire was prepared for an ffr procedure. However, the pa displayed an error message of "no source". Upon checking the wi-box, both the red and green light were on. The cables were unplugged, and replugged but the quantien displayed an error message of "signal lost". The ao in was then unplugged, and both the lights on the wibox (green and red) were turned on again, and the quantien displayed error message of "no source". The procedure was unable to proceed and was rescheduled. The wi-box was inspected and was determined to be faulty. It was then replaced, and the issue was resolved.

• Brand Name: WI-BOX
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8528504
• MDR Text Key: 142392105
• Report Number: 2184149-2019-00041
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K111854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: C12783
• Device Lot Number: 6391658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse