MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC CRITIKON CLASSIC CUF SIZE 3 NEONATE BLOOD PRESSURE CUFF

Model Number 2128

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

While taking a blood pressure using the size 3 neonatal cuff, the cuff burst.No harm to neonate.Treatment dates start: (b)(6) 2020, treatment dates stop: (b)(6) 2020.Diagnosis for use: blood pressure monitoring.Fda safety report id # (b)(4).

• Brand Name: CRITIKON CLASSIC CUF SIZE 3 NEONATE BLOOD PRESSURE CUFF
• Type of Device: BLOOD PRESSURE CUFF
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
• MDR Report Key: 10740159
• MDR Text Key: 213482506
• Report Number: MW5097468
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): Y
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 DA