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

Model Number VMP306PX

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2018

Event Type  malfunction  

Event 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.
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7540245
• MDR Text Key: 109149103
• Report Number: 7540245
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07460691950375
• UDI-Public: (01)07460691950375
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: VMP306PX
• Device Catalogue Number: VMP306PX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1