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

Model Number HEMO V. 9.20

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operational Issue (2914)

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

Event Date 05/05/2014

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Merge hemo monitors, measures, and records physiologic data from human patients undergoing a cardiac catheterization procedure.Customer reported hemo monitor crashed with an error hemomonitor.Exe error.The site lost vitals monitoring and logs attached.(b)(4).

• 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; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437924
• MDR Text Key: 38226571
• Report Number: 2183926-2015-00388
• 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: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMO V. 9.20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2183926-02/15/2016-031-C
• Patient Sequence Number: 1