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

Model Number MERGE HEMODYNAMICS 10.0.1

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Merge healthcare has made many troubleshooting efforts to correct the customer's reported problem.Simulated testing was performed and a "cable off" error message was received.The patient data module (pdm) was switched out and the customer's test results showed the unit worked properly.However, the same problem occurred when used on a patient, so the cabling was adjusted and it appeared to work correctly.However, the customer has requested that the case remain open until it is certain that the problem has been corrected.A replacement pdm was shipped to the customer on 3/21/2016.(b)(4).

Event Description

Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the hemodynamics hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that problems have been experienced with the hemo cardiac output function.Information obtained from the customer indicated that patients' waveforms were presenting as a "stair step line" instead of a bell curve formation and the values were "way off." it was further stated that there have been twelve (12) patients affected to-date - four patients have had more "normal" shaped waveforms, however the values were noticeably incorrect.The remaining eight (8) patients have not had this part of testing completed because of the problem.The customer further stated that this has been on-going issue for about two (2) months so the exact dates of occurrence are unknown.With merge hemo presenting incorrect physiological data during treatment, there is a potential for incorrect treatment that results in harm to the patient.However, the customer stated that the incorrect values were recognized by the medical staff and were not used for treatment purposes.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• 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 drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5577736
• MDR Text Key: 42768674
• Report Number: 2183926-2016-00545
• 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: Other
• Type of Report: Initial
• Report Date: 03/16/2016

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 HEMODYNAMICS 10.0.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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