MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GE MAC VU360; ELECTROCARDIOGRAPH

Model Number MACVU 360

Patient Problems Exposure to Body Fluids (1745); Erythema (1840); Pain (1994); Burning Sensation (2146); Discomfort (2330); Swelling/ Edema (4577)

Event Date 08/10/2023

Event Type  Injury  

Event Description

At approximately 9:25pm, a code red fire alarm was activated in the emergency department (ed) on the (b)(6).While using a portable ekg machine to examine a patient, the nurse observed orange in color flames coming out of the side of the machine under the keyboard area.The ekg machine exploded and sent debris across the room.The nurse attempted to shield the patient, but he was struck in the right eye by debris causing him pain, discomfort, redness and possible burns.The nurse immediately shut off the oxygen supply and was able to push the machine into the hallway to protect the patient.The nurse sustained a bruised to her left upper arm area and swelling to her left eye due to burning and soreness.Both were treated for their injuries in the ed and were examined by a provider from the eye clinic who stated that their injuries do not appear to be serious.Fire was quickly put out by (b)(6) police utilizing a fire extinguisher.Bio-med was notified and retrieved the ekg machine and preservation of debris va wny healthcare system in process of removing batteries from all mac vu 360 ekg machines.Waiting for vendor to arrive onsite.They will not be permitted to remove involved items from the premises.Incident investigation is in progress.

• Brand Name: GE MAC VU360
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• MDR Report Key: 17549079
• MDR Text Key: 321159881
• Report Number: MW5144532
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/11/2023

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: MACVU 360
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening