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

Model Number MERGE HEMODYNAMICS 8.10

Device Problems Circuit Failure (1089); Device Issue (2379)

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

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

The complainant device was returned by the customer for evaluation on 3/21/2016.The aluminum electrolytic capacitors had failed and a hazardous substance had leaked out, believed to be an electrolyte paste.Subsequently, the motherboard was replaced and software was reinstalled.The device underwent diagnostic testing for two (2) days.The system passed and was then returned to service stock.Further investigation found industry safety precautions for such a device: "if the capacitor is mechanically, thermally, or electrically abused to the point of compromising the enclosure, toxic and hazardous internal components may be exposed.Skin contact with electrolyte can cause severe chemical burns.Eye contact with electrolyte rapidly causes severe damage with risk of permanent eye damage.Ingestion of electrolyte may cause severe injury or permanent damage." this is a known issue with capacitors that were manufactured more than 5 years ago and is commonly referred to in industry as the "capacitor plague.".

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 the motherboard failed in the hemo client pc which resulted in blown capacitors that leaked a hazardous substance.There was no report of user or patient harm during this event.A report of a leaked substance can lead to a potentially hazardous situation for users and/or patients.(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: 5553104
• MDR Text Key: 42037150
• Report Number: 2183926-2016-00529
• 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: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 8.10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2012
• 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