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.

Manufacturer Narrative

One wi-box was received into the lab for analysis with no accessories or original packaging available for inspection.Visual inspection of the returned wi-box confirmed no physical damage was observed, all labels are intact & legible.A functional test was performed utilizing a known good quantien unit upon which the returned wi-box failed to establish communication & all indicator led¿s (light emitting diodes) were illuminated, confirming the field reported event.Based on the information provided to abbott and the investigation performed, the field reported event citing unestablished communication was successfully reproduced.Root cause of this abnormal behavior was isolated to a non-serviceable system level component.

• 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
• 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
• PMA/PMN Number: K111854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Model Number: C12783
• Device Lot Number: 6391658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1