MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. PACEART; ELECTROCARDIOGRAPH

Model Number P127

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 08/13/2010

Event Type  malfunction  

Event Description

It was reported the module is producing ecgs (electrocardiograms) that are too small or too tall and narrow to be readable.The ecg module was returned for exchange/swap.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event was assessed and is being reported as a part of a retrospective review of events, which was in response to mdr criteria revisions and on-going process improvements.Product event summary: analysis found the device had contamination in the usb (universal serial bus) connectors which was determined to be a potential cause for the reported event.(b)(4).

• Brand Name: PACEART
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 372
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4609736
• MDR Text Key: 21834226
• Report Number: 2183613-2015-00265
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/13/2010

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: P127
• Device Catalogue Number: P127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2010
• Initial Date FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1