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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. MAC VU360 RESTING ECG ANALYSIS SYSTEM ELECTROCARDIOGRAPH

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CRITIKON DE MEXICO S. DE R.L. DE C.V. MAC VU360 RESTING ECG ANALYSIS SYSTEM ELECTROCARDIOGRAPH Back to Search Results
Device Problems Smoking (1585); Sparking (2595); Device Handling Problem (3265)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2020
Event Type  Malfunction  
Manufacturer Narrative

Patient information not provided ge healthcare investigation is ongoing. A follow-up report will be submitted when the investigation is complete legal manufacturer: hcs tower - (b)(4).

 
Event Description

The customer alleged a spark and smoke occurred on the cable that runs between the acquisition module (cc14) and the mac vu360 while connected to a patient. There was no patient injury.

 
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Brand NameMAC VU360 RESTING ECG ANALYSIS SYSTEM
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
CRITIKON DE MEXICO S. DE R.L. DE C.V.
calle valle del cedro 1551
juarez 32575
MX 32575
Manufacturer Contact
kristof soos
8200 w tower avenue
milwaukee, WI 
MDR Report Key10546865
MDR Text Key208173733
Report Number3008729547-2020-00006
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173830
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Date Returned to Manufacturer09/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/24/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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