MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE, VAMP JR.; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	VMP306PX
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Vamp jr transducer would not read arterial blood pressure or pulse rate.New transducer was obtained and worked appropriately.Device is in my possession however packing was not retained.

• Brand Name: TRUWAVE, VAMP JR.
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7540245
• Report Number: 7540245
• Device Sequence Number: 19307634
• Product Code: DXO
• UDI-Device Identifier: 07460691950375
• UDI-Public: (01)07460691950375
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2018
• Report Date (Section F): 05/18/2018

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: Nurse
• Device Model Number: VMP306PX
• Device Catalogue Number: VMP306PX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2018
• 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: 05/18/2018