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

Model Number MERGE HEMO V. 9.30

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Data Problem (3196)

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

Event Date 06/07/2014

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The merge hemodynamic recording system is used to monitor o2 saturation while performing cardiac catheterization procedures.It was reported that the spo2 value was freezing on the hemo monitor.If pulse rate is being measured using the spo2 values, then the pulse rate also freezes, which causes the hemo monitor to display stale data.The site reported that the oxygen saturation values (spo2) stopped working on version 9.30 of merge hemo.

• Brand Name: MERGE HEMODYNAMICS
• 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: 5339674
• MDR Text Key: 34885728
• Report Number: 2183926-2015-00103
• 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

• Date FDA Received: 01/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMO V. 9.30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2183926-9/24/2014-002-C
• Patient Sequence Number: 1