MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number H700150

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  Injury  

Event Description

During device preparation, with the patient prepped under general anesthesia, an amplifier error message displayed that read, "amplifier is off or not connected, please check the connection".The device was power cycled but the issue remained, so the procedure was cancelled.There were no adverse consequences to the patient.

Manufacturer Narrative

Based on the results of the hardware evaluation performed, it was concluded that the returned amplifier functioned as expected.The hardware evaluation focused on the basic functions of the returned amplifier such as communication, signals acquisition/amplification and data processing.No abnormal operating symptoms or unexpected abnormal functions under normal operating condition were observed.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 abbott specifications and procedures.Based on the information provided and the hardware evaluation performed, the cause of the reported communication issue could not be conclusively determined.

• Brand Name: WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• 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: 7146259
• MDR Text Key: 95768226
• Report Number: 2184149-2017-00079
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 5544879
• Other Device ID Number: 05415067001504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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