MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE MONITOR B850; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number CARESCAPE DI9KT

Device Problem Defective Alarm (1014)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Vomiting (2144); Loss Of Pulse (2562)

Event Date 02/25/2019

Event Type  Death  

Event Description

Staff noticed patient's heart rate was 20-30 and asked if the patient was a do-not-resuscitate comfort care (dnrcc).I overheard this discussion and went in to patient's room where i found the patient to be in pulseless electrical activity and vomiting and immediately begun chest compressions and yelled for code blue to be activated.Staff reviewed the heart rate alarm after the code blue and it appeared to be on and set to alarm if heart rate went below 50.

• Brand Name: CARESCAPE MONITOR B850
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 465 pan american dr ste 11; el paso TX 79907
• MDR Report Key: 8424033
• MDR Text Key: 138892843
• Report Number: 8424033
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2019

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: No Information
• Device Model Number: CARESCAPE DI9KT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29930 DA
• Patient Weight: 63