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

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

Legal manufacturer: hcs tower - 8200 w tower ave usa milwaukee, wi 53223 a1-a6: this information was not provided by the customer.The customer reported a loss of audible alarm function on the cic pro.On follow-up with the customer, there was no related adverse patient consequence, nor allegation that the issue led to a missed patient event.The biomedical engineer rebooted the cic pro which restored the audio function.Per review with ge healthcare (gehc) engineering, this event was determined to be related to a previously investigated issue wherein the cic pro device may lose audible alarm function.The visual alarms are still present and active.If the patient is also connected to a bedside monitor, the alarms at the bedside monitor are unaffected.Gehc attempted to reproduce the issue with similar devices in a test lab, reviewed device performance log files for other devices that showed the same issue, and performed extensive historical data analysis along with technical design review.Gehc was unable to determine a definitive root cause for the loss of audible alarm function.Gehc continues to evaluate incoming complaints and investigate where appropriate.

Event Description

The customer reported a loss of audible alarm function on the cic pro.There was no related adverse patient consequence.

• Brand Name: CIC PRO
• 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 53223
• MDR Report Key: 19192319
• MDR Text Key: 341247970
• Report Number: 3008729547-2024-00005
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032370
• 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
• Report Date: 04/26/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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