MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FLOTRAC, VAMP; TRANSDUCER, BLOOD-PRESSURE

Model Number	MHD6AZ
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The end of device where the stopcock is located was "wobbly".Nurse unscrewed it from the white rectangular portion and bits of plastic fell out.

• Brand Name: FLOTRAC, VAMP
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 8431573
• Report Number: 8431573
• Device Sequence Number: 1634062
• Product Code: DRS
• UDI-Device Identifier: 00690103194722
• UDI-Public: (01)00690103194722
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/12/2019
• Report Date (Section F): 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MHD6AZ
• Device Catalogue Number: MHD6AZ
• Device Lot Number: 61719567
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/12/2019