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

Model Number 10.0.1

Device Problems Detachment Of Device Component (1104); No Display/Image (1183)

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

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that the issue was caused by a loose connection due to a missing screw on the vga plug on the cable that connects the pdm to the merge hemo record station computer.

Event Description

A customer reported that the merge hemo record station's computer display stopped working during a coronary intervention case.The screen went black and the mouse cursor on the screen was frozen.The patient data module (pdm) started beeping when data stopped transmitting from the pdm to the merge hemo record station.The physician checked all connections to the pdm (which appeared to have been connected), and rebooted the computer.The merge hemo display came back on while the physician was re-enforcing the pdm connections, not necessarily right when the computer rebooted.The system was down for a total of approximately 4-8 minutes, according to the user, thus there was a delay in patient care.The physician was able to user merge hemo to continue with the procedure after the connection was re-established and there is no report of any adverse effect on the patient due to the delay.It was determined that the issue was caused by a loose connection, which was due to a missing screw on the vga plug on the cable that connects the pdm to the merge hemo record station computer.

• Brand Name: MERGE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE INCORPORATED; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5317131
• MDR Text Key: 34074907
• Report Number: 2183926-2015-00004
• 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: health professional
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10.0.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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 Age: 57 YR
• Patient Weight: 83