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

Device Problems Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

Patient was going to transfer from to icu, needed to go to ct department first with primary rn accompanying patient on dash monitor.Dash monitor lost power while patient in ct department.Theorized that dash had been unplugged for a long time or plug connection to machine was loosened, or that battery will not sustain charge.It did not seem like it had been in the patient's room very long before transferred to ct department.Primary rn and charge rn checked that connection of plug to back of machine was snug.Biomed inspected both dash machines afterward and did replace one of the batteries in one of the dash monitors (each have 2 batteries).Auditors will be asked to pay close attention that "charging light on" displays on front of dash.Staff will be asked to keep dash plugged in at all times with "charging light on".Change of battery by biomed may have resolved contributing factor.Listing both serial numbers in report, as unable to distinguish which dash malfunctioned.

• Brand Name: DASH 4000
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES; 8200 west tower avenue; milwaukee WI 53223
• MDR Report Key: 10413176
• MDR Text Key: 203121204
• Report Number: 10413176
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 07/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14235 DA