MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS

Model Number 6.6.2

Device Problem Device Issue (2379)

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

Event Date 03/12/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Merge pacs (picture archiving communication system) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.Customer reported that priors are not getting sent to a 6.5.9 system via telmed.They use an after hours reading service and are calling this a patient care issue.There is no indication that the studies failed.Research narrowed the issue to sending only lossy images which have been qc'd and only sending to an older version of pacs.Development has determined there is a defect in pacs and will be fixing it in 6.6.3.(b)(4).

• Brand Name: MERGE PACS
• Type of Device: PACS
• 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: 5437765
• MDR Text Key: 38227827
• Report Number: 2183926-2015-00421
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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: 6.6.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-02/15/2016-051-C
• Patient Sequence Number: 1