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

Model Number MERGE HEMO 9.20

Device Problems Loss of Data (2903); Data Problem (3196)

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

Event Date 05/20/2013

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 waveform recordings are not full time length.It was noted that from time to time the system is not recording for the full eight seconds.Two recordings on the aortic opening (ao) were noted as five beats for the first and a full 10 beats for the second.

Manufacturer Narrative

Supplemental to add recall update and fda recall reference numbers.Recall is closed.Fda recall number z-2347-2015; res 71814.

Manufacturer Narrative

Added fda recall reference numbers.

• 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: 5339613
• MDR Text Key: 34924151
• Report Number: 2183926-2015-00032
• 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,Followup,Followup
• Report Date: 12/31/2015

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: MERGE HEMO 9.20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2013
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: 05/20/2013; 05/20/2013
• Supplement Dates FDA Received: 11/13/2017; 11/13/2017
• 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: Reuse
• Removal/Correction Number: FDA RECALL NUMBER Z-2347
• Patient Sequence Number: 1