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

Model Number MERGE HEMO 9.40

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Nonstandard Device (1420); Loss of Power (1475); Difficult or Delayed Activation (2577); Device Displays Incorrect Message (2591); Data Problem (3196)

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

Event Date 10/30/2014

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 phase-in 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 rapid repeat pressures during the merge hemo installation process.It was noted that after rebooting the client computer and starting the procedure on the patient, there was an issue with using the full disclosure record for all of the waveforms they needed for the case.The customer also reported that the system had thrown an error previously and the application would shut down or kick them out.

• Brand Name: MERGE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5339688
• MDR Text Key: 35280175
• Report Number: 2183926-2015-00035
• 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: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMO 9.40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• 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