MAUDE Adverse Event Report: GENERAL ELECTRIC HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC DASH 4000 MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number REF2035598

Device Problem No Audible Alarm (1019)

Patient Problems Abdominal Pain (1685); Cardiopulmonary Arrest (1765); Death (1802); High Blood Pressure/ Hypertension (1908)

Event Date 06/18/2020

Event Type  Death  

Event Description

Patient arrived in emergency department for evaluation and treatment of abdominal pain and elevated blood pressure.During a routine check, asystole was witnessed on the cardiac monitor as the nurse entered the room.Cpr was immediately implemented.The monitor was visually working however, no alarms were audibly alerting the nursing staff of a cardiac event.Volume settings on the monitor were on and turned up to 50% but no sound was heard.Fda safety report id# (b)(4).

• Brand Name: DASH 4000 MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GENERAL ELECTRIC HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC; milwauke WI
• MDR Report Key: 10178512
• MDR Text Key: 196066185
• Report Number: MW5095087
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2020

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: REF2035598
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• 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: 26 YR
• Patient Weight: 81