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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.
 
Manufacturer Narrative
The investigation revealed the user improperly placed the cc14 acquisition module in the holder.Improper placement stressed the cable and damaged it, resulting the internal conductors shorting.This issue was caused by user misuse.
 
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Brand Name
MAC VU360 RESTING ECG ANALYSIS SYSTEM
Type of Device
ELECTROCARDIOGRAPH
Manufacturer (Section D)
CRITIKON DE MEXICO S. DE R.L. DE C.V.
calle valle del cedro 1551
juarez 32575
MX  32575
MDR Report Key10546865
MDR Text Key208173733
Report Number3008729547-2020-00006
Device Sequence Number1
Product Code DPS
UDI-Device Identifier00840682125499
UDI-Public01008406821254994
Combination Product (y/n)N
PMA/PMN Number
K173830
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/19/2020
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
Was Device Available for Evaluation? No
Date Returned to Manufacturer09/11/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/19/2020
Initial Date FDA Received09/17/2020
Supplement Dates Manufacturer Received11/06/2020
Supplement Dates FDA Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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