MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY CARESCAPE B850; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 2039143-001

Device Problems Failure to Power Up (1476); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

The anesthesia machine mentioned wasn't turning on for the first case of the day.Anesthesiologist asked for help from anesthesia tech and was able to fix it before they brought the patient in the room.The said monitor functioned well without a problem throughout the first case.The second case of the day was scheduled for afternoon.After the patient was intubated and the anesthesiologist was in the process of putting on another iv line the said monitor died.Despite the effort of the anesthesia tech and biomed to fix it, the said monitor wouldn't turn back on.We ended up hooking the patient to a transport monitor temporarily while the anesthesiologist continuously used the ambu bag to the patient and the anesthesia tech and biomed worked together to changed the anesthesia monitor.Jmh spark# 67386.Biomed received a call from anesthesia tech, anesthesia unit was removed from the operating room and placed in storage area for troubleshooting.Further troubleshooting revealed that the b850 display monitor was defective.While removing the display monitor also notice a broken pin in the connector of the video cable.Replaced the b850 display monitor and video cable.Performed operational check and verified display is present and touch screen fully functional.Anesthesia cart was then placed back into service, anesthesia tech then performed the full leak test on anesthesia cart and biomed verified data flowing.

• Brand Name: CARESCAPE B850
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; 3000 n. grandview blvd.; waukesha WI 53188
• MDR Report Key: 13720008
• MDR Text Key: 286921638
• Report Number: 13720008
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/02/2022

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: Other
• Device Model Number: 2039143-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Female