MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. RADIANALYZER¿ XPRESS¿; COMPUTER, DIAGNOSTIC, PROGRAMMABLE; COMPUTER, BLOOD-PRESSURE

Model Number C12711

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

When the radianalyzer xpress monitor was turned on, an electrical spark and smoke from the power supply was reported.No patient was involved.

Manufacturer Narrative

Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.The correct mfr number is 8030904.

Manufacturer Narrative

Product evaluation: based on the information provided to abbott and the investigation performed, root cause of the field reported event citing a thermal event in the power supply was successfully isolated to a damaged resistor at the r9 location of the printed circuit assembly.

• Brand Name: RADIANALYZER¿ XPRESS¿
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE; COMPUTER, BLOOD-PRESSURE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; palmbladsgatan 10, box 6350; uppsala MN SE-75 1 35; SW SE-751 35
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7041214
• MDR Text Key: 92873091
• Report Number: 2184149-2017-00055
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K092105
• 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,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C12711
• Device Catalogue Number: C12711
• Other Device ID Number: 05414734050654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other