MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMO; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 9.40

Device Problems Erratic or Intermittent Display (1182); Device Operational Issue (2914)

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

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

During cath lab procedures while using the phasein etco2 option for merge hemo, the system could occasionally become non-responsive to user actions (freezes up), the record button might become grayed out and unable to start /stop recording, or multiple short recordings might be displayed versus the typical long, continuous recording.A customer reported that they observed excessive status messages for the co2 module after a disconnection of the module from the merge hemo system.Physicians are reluctant to allow the system to be rebooted to clear the error condition because it results in a temporary (during the reboot) loss of display of vital signs during the invasive procedure being performed on the patient.

• Brand Name: MERGE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5339695
• MDR Text Key: 34886812
• Report Number: 2183926-2015-00069
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9.40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2015
• Initial Date FDA Received: 01/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-7/27/2015-001-C
• Patient Sequence Number: 1