MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. CIC; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem No Audible Alarm (1019)

Patient Problem Cardiac Arrest (1762)

Event Date 08/21/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

It was reported that a patient was found in cardiac arrest and the cic central station did not audibly alarm.

Manufacturer Narrative

The customer reported that the cic pro did not audibly alarm for an asystole condition.The patient was found in cardiac arrest but, due to his do not resuscitate status, cpr was not initiated and the patient subsequently expired.It was acknowledged that the bedside monitor visually and audibly alarm for the event.In addition, the customer stated that visual alarms were still present on the cic pro.Moreover, it was not alleged that the loss of audible alarms contributed to the patient's death.The customer's biomedical tech confirmed that the cic pro was not producing audible alarms for any patient on the unit.The cic pro cpu and hard drive were sent to ge healthcare engineering, whereupon testing, the issue could not be reproduced.Gehc's investigation included testing other devices that reported the issue, the review of device log files, follow-up with the customer, and extensive historical data analysis along technical design review.Gehc concluded that a definitive root cause could not be determined.Gehc continues to evaluate complaints and investigate where appropriate.

• Brand Name: CIC
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• 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 53221
• MDR Report Key: 12661803
• MDR Text Key: 277340010
• Report Number: 3008729547-2021-00005
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K032370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male