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

Model Number MERGE HEMO 7.20

Device Problems Device Emits Odor (1425); Smoking (1585); Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was returned to merge healthcare's (b)(4) site.A replacement (b)(4) pc was sent to the customer.Motherboard electrolytic capacitor failures are common in computers >5-10 years old.

Event Description

Merge hemo monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.On (b)(6) 2016, a customer reported to merge healthcare that the hemo monitoring pc was not booting up and smoke could be smelled coming from the pc.There was no patient present and the catherization lab was not in use at the time.A report of smoke can lead to potentially hazardous situations for users and/or patients.The customer did confirm that there was no harm to any patients or users.The customer was provided a replacement hemo monitoring pc and an analysis of the returned pc identified two failed aluminum electrolytic capacitors on the mother board.(b)(4).

• Brand Name: MERGE HEMO
• 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; harland, WI 53029 ; 2629123570
• MDR Report Key: 5446619
• MDR Text Key: 39105712
• Report Number: 2183926-2016-00448
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2016

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 HEMO 7.20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Device Age: 8 YR
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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