MAUDE Adverse Event Report: MERGE HEALTHCARE ICONNECT ENTERPRISE ARCHIVE; IMAGE ARCHIVE

Model Number 5.35.5

Device Problem Data Problem (3196)

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

Event Date 11/15/2015

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, this issue was determined to be reportable as an mdr.Engineering has evaluated and assessed this device malfunction.A fix has been implemented in version 9.4.4.1.

Event Description

Iconnect enterprise archive a vendor neutral archive for storage and communications of medical images and data.A customer called to inform merge healthcare that an error message is displaying while reading a ct scan.The error message is preventing the radiologists from comparing the ct studies with priors.This event can impact patient care since the radiologists need to have results for stroke alerts within 45 minutes.The radiologists are having to reboot the pc to clear this error.The customer did not report a serious injury to the patient.(b)(4).

• Brand Name: ICONNECT ENTERPRISE ARCHIVE
• Type of Device: IMAGE ARCHIVE
• 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 rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5437789
• MDR Text Key: 38228043
• Report Number: 2183926-2016-00001
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE, EXEMPT
• 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
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5.35.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-067-C
• Patient Sequence Number: 1