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

Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.

• Brand Name: MAC VU360 RESTING ECG ANALYSIS SYSTEM
• Common Device Name: 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 Key: 10546865
• Report Number: 3008729547-2020-00006
• Device Sequence Number: 11060967
• Product Code: DPS
• UDI-Device Identifier: 00840682125499
• UDI-Public: 01008406821254994
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1