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

Model Number MERGE HEMO 9.30

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Missing Value Reason (3192)

Patient Problem Death (1802)

Event Date 08/17/2014

Event Type  Death  

Manufacturer Narrative

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

Event Description

Customer reported that during a case vitals capture (for documenting vital signs data in the chronological record for the procedure) stopped working due to nibp failures.The user expects that when an automatic interval is set for vitals capture it should be followed by the system.However, in this case, the staff didn't realize the vitals capture had stopped.The patient died after leaving the cath lab and the customer does not feel merge hemo contributed to the patient's death.The patients' vital signs (minus the nipb) plus the live ecg and invasive pressures were always visible on the hemo screen.Also, the system is designed to stop vitals capture during use if nibp measurements stop.

• 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: 5339192
• MDR Text Key: 34870523
• Report Number: 2183926-2015-00022
• 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
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MERGE HEMO 9.30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2013
• 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 Outcome(s): Death