MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. MAC VU 360 RESTING ECG ANALYSIS SYSTEM; ELECTROCARDIOGRAPH

Model Number 2030360-001

Device Problems Battery Problem (2885); Insufficient Information (3190)

Patient Problems Eye Injury (1845); Eye Pain (4467)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

Block a1, a2 and a4 : patient information not currently available.Block d4: udi - (b)(4).Ge healthcare investigation is ongoing.A follow up report will be submitted when the investigation has been completed.Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.Ge healthcare investigation is ongoing.A follow up report will be submitted when the investigation has been completed.

Event Description

A nurse sustained injuries from a reported fire/explosion from a mac vu360.

Manufacturer Narrative

Block h6 _clinical code: e2005.Investigation findings: the reported issue was caused by a thermal runaway due to the sudden internal short circuit within a cell of the totex battery.This resulted in the mac vu360 exploding.Consequently, a nurse sustained a bruise to left upper arm and swelling to her left eye due to burning and soreness.The nurse was treated for the injures in the emergency room and examined by a clinician from an eye clinic, which it was reported, the injures did not appear to be serious.Details of the medical treatment were not provided to gehc.This incident is unique to gehc as no other similar incidents have been reported.Based on the investigation, there is no evidence of design deficiency of the device identified.

• Brand Name: MAC VU 360 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
• Manufacturer (Section G): 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 ave; milwaukee, WI 53223
• MDR Report Key: 17712297
• MDR Text Key: 322979463
• Report Number: 3008729547-2023-00007
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2030360-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female