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

Model Number	PATIENT DATA MODULE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse attempted to take a blood pressure of a patient and was unable to.Also replaced the cuff and the tubing with the same result so the module was taken out of service and returned to the manufacture for a warranty repair.Manufacturer response for monitor, physiological, patient (with arrhythmia detection or alarms), ge (per site reporter).They replaced the main board and calibrated.

• Brand Name: GE
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 16589859
• Report Number: 16589859
• Device Sequence Number: 12093945
• Product Code: MHX
• UDI-Device Identifier: 00840682104784
• UDI-Public: (01)00840682104784
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/13/2023
• Report Date (Section F): 03/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: PATIENT DATA MODULE
• Device Catalogue Number: 2016793-103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/13/2023