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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. PACEART ELECTROCARDIOGRAPH
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MEDTRONIC MILACA, INC. PACEART ELECTROCARDIOGRAPH Back to Search Results
Model Number P127
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2010
Event Type  Malfunction  
Event Description

It was reported the module generates a lot of noise/artifacts on the ecgs (electrocardiograms). The device 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 could not confirm the reported event; device passed functional testing. (b)(4).

 
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Brand NamePACEART
Type of DeviceELECTROCARDIOGRAPH
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 Key4609730
MDR Text Key5631149
Report Number2183613-2015-00266
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK024278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/23/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberP127
Device Catalogue NumberP127
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/31/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/23/2010
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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