MAUDE Adverse Event Report: GE CIC PRO CARESCAPE; DETECTOR AND ALARM, ARRHYTHMIA

Model Number CIC PRO

Device Problem No Audible Alarm (1019)

Patient Problems Hypoxia (1918); Respiratory Failure (2484); Cognitive Changes (2551); Diminished Pulse Pressure (2606); Asystole (4442); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/21/2021

Event Type  Death  

Event Description

Event as described by clinical staff: the patient had high co2 and was placed on bipap with a diagnosis of chf.Given lasix to help with oxygenation.Pt was confused and did not want to keep the bipap-patient wanted to go home.The patient transitioned to airvo as per discussion with dr and rts for comfort.The patient is on 80% oxygen.Pt remained confused and was attempting to remove foley and oxygen.The patient was placed in chest restraint only.Mrn was on break around 1800.Pt found by dr to be in asystole with no palpable pulse in a believed respiratory failure due to hypoxemia.Nurses covering for the patient did not hear asystole alarms.Doors closed as pt on airborne precautions.Device problem: the patient was attached to a ge b650 bedside monitor in the er and was in a room with the doors closed.The unit has a cic pro communicating to all bedside monitors in unit rooms.The alarm on the bedside monitor went off, but clinical staff was not notified of the fact as the cic pro did not reproduce an audible alarm.The cic pro reproduced a visual alarm only.Initial troubleshooting by biomed triggered alarms on the b650 and confirmed a visual and audible alarm on the bedside monitor.Confirmed that the b650 communicates properly with the cic pro.Ruled out any issues regarding the b650.Checked the cic pro and confirmed a visual alarm but no audible one (video evidence can be provided by request).Verified proper alarm settings and volume was turned up.Verified speakers were working.Attempted to use a different set of speakers.Cleaned aux port.Still no audible alarm.Triggered an alarm from a different bedside monitor and confirmed the issue was not isolated to one bed.Restarted the cic pro and still no audible alarm ¿ rebooting the system does not bring back the audio.Ge's investigation results: summary of findings: ge could not replicate the issue and did not find anything wrong with the system.Device log and volume system indicate that audible alarms should have been produced by cic; configuration of b650 was correct, audible alarms should have been there.Ge cannot confirm what contributed to the identified issue.Fda safety report id# (b)(4).

• Brand Name: CIC PRO CARESCAPE
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): GE; vancouver, bc ; CA
• MDR Report Key: 15292776
• MDR Text Key: 298666803
• Report Number: MW5111693
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/22/2022

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
• Device Model Number: CIC PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 92 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic