MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS PHILIPS X2; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Problems Unintended System Motion (1430); Device Fell (4014)

Patient Problem Laceration(s) (1946)

Event Date 05/27/2022

Event Type  Injury  

Event Description

Phillips monitor became lose from mount and fell striking the baby's forehead.Causing 3 cm laceration requiring sutures.Fda safety report id # (b)(4).

• Brand Name: PHILIPS PHILIPS X2
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 14788144
• MDR Text Key: 294670378
• Report Number: MW5110461
• 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: 06/20/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 DA
• Patient Sex: Male