MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUANTIEN; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number C12787

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

The quantien system could not be turned on to view a case because it was wet with contrast.A short circuit occurred, and a spark was noted.There was no patient involvement.

Manufacturer Narrative

One quantien was returned for analysis.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event was isolated to fluid ingress to the power supply unit which resulted in the subsequent short circuit.

• Brand Name: QUANTIEN
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8369581
• MDR Text Key: 137126284
• Report Number: 2184149-2019-00020
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067000996
• UDI-Public: 05415067000996
• Combination Product (y/n): N
• PMA/PMN Number: K123984
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C12787
• Device Lot Number: 9999999999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1