MAUDE Adverse Event Report: ST. JUDE MEDICAL SYSTEMS QUANTIEN; COMPUTER, DIAGNOSTIC, PROGRAMMABLE; COMPUTER, BLOOD-PRESSURE

Model Number C12787

Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)

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

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the information provided to st.Jude medical and the investigation performed, the cause of the reported event was isolated to loss of direct current from the power supply due to fluid intrusion which resulted in a shorted electrical circuit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.During testing for the international standard, the power supply unit (psu) and the system, when properly installed, passed all requirements.The specific system for this event was installed by an abbott employee.It was reported that the psu was on the floor and not captured within the mounting mechanism, which abbott believes led to the fluid ingress.The situation with the psu on the floor could occur as a result of incorrect installation or a configuration change by hospital staff after the initial installation.The quantien ifu instructs the user to not use the quantien system if it has been dropped or in any other way exposed to mechanical or electrical damage, or if liquid is suspected to have penetrated the enclosure or the power supply unit.This can cause the user or patient to be exposed to electric shock.

Event Description

The quantien system green led light was not lit and would not boot up.The cath lab nurse tried to reconnect a cable with the power supply unit (psu) and received an electric shock, but the nurse was reported to be fine.The quantien system was powered with a socket located under the cath lab table and the quantien system was mounted directly on a pole on the table.There were no products connected to the system at the time of the event.

• Brand Name: QUANTIEN
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE; COMPUTER, BLOOD-PRESSURE
• Manufacturer (Section D): ST. JUDE MEDICAL SYSTEMS; palmbladsgatan 10, box 6350; uppsala SE-75 1 35; SW SE-751 35
• Manufacturer (Section G): ST. JUDE MEDICAL SYSTEMS; palmbladsgatan 10, box 6350; uppsala SE-75 1 35; SW SE-751 35
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 6439614
• MDR Text Key: 71051086
• Report Number: 8030904-2017-00001
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C12787
• Device Catalogue Number: C12787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other