MAUDE Adverse Event Report: ADVANCE MEDICAL SOLUTION MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS); MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number B125

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problems Head Injury (1879); Laceration(s) (1946)

Event Date 10/23/2020

Event Type  Injury  

Event Description

This letter is to inform you of an event that occurred at (b)(6) in on (b)(6) 2020.It was reported to ge healthcare (gehc) on october 23, 2020 that a b125 patient monitor fell and struck a patient in the head.The patient sustained a laceration as a result and required four stitches.No further medical treatment was required.It was determined the base plate of the wall mount came loose which caused the monitor to fall; there were no issues identified with the monitor.The wall mount system was installed by a third-party service provider and is not approved for use by gehc.The customer has been informed of the approved mounting solution for this patient monitor.The failed mounting system in this event is neither manufactured nor distributed by gehc.The manufacturer of the mount is advance medical solution of new delhi, india.The manufacturer of the mounting system has been notified of the event.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): ADVANCE MEDICAL SOLUTION
• MDR Report Key: 17535484
• MDR Text Key: 321157108
• Report Number: MW5142381
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2020

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?: No
• Device Model Number: B125
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1