MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE AIMS; ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM

Model Number MERGE AIMS 8.0

Device Problem Computer Software Problem (1112)

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

Event Date 01/21/2011

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6) reported that the infusion total in merge aims was sometimes incorrect on the anesthesia record grid.A defect in the code causes commas to be treated as decimal places when displaying the sum of administered volumes in the anesthesia record grid.Example: the system adds commas to values greater than or equal to 1000 (e.G.1,000) but when summing these values on the anesthesia record grid the comma is being treated as a decimal (so 1,000 is treated as 1.0).If an incorrect infusion volume is believed to be correct, additional fluids could be administered when not needed.

• Brand Name: MERGE AIMS
• Type of Device: ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr.; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge dr.; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5339165
• MDR Text Key: 34924041
• Report Number: 2183926-2015-00019
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062388
• 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: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE AIMS 8.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-01/04/2016-029-C
• Patient Sequence Number: 1