MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number H700150

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  Injury  

Event Description

During preparation for the procedure, with the patient on the table, the amplifier screen froze twice with a packet rate error.The issue was not resolved and the procedure was cancelled.

Manufacturer Narrative

The reported communication issue resulting in a cancelled procedure was reproduced during the hardware evaluation.During an extended communication test an error "amplifier disconnected" message was displayed indicating that the communication between the workmate claris system and amplifier was terminated unexpectedly.The root cause of the amplifier connection issue was isolated to an intermittent abnormal functioning single board computer module.The issue was resolved after replacing the single board computer module with a known good unit and confirmed that the amplifier passed the extended communication test without further issues.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER
• Type of Device: CARDIAC CATHETERIZATION MONITORING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7130692
• MDR Text Key: 95267676
• Report Number: 2184149-2017-00077
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 6130886
• Other Device ID Number: 05415067001504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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