MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PL2601TS_

Device Problem Low Readings (2460)

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

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

Received one single dpt kit with pressure tubing.The dpt zeroed and sensed pressure accurately on the pressure monitor.The pressure did not show any drifting during the output drift testing and met specifications as well.The electrical testing showed that the dpt electronic components were intact because both input impedance and output impedance were within specifications.The zero-offset also met specifications.No visible defect was found from the dpt cable connector.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that inaccurate arterial value was shown on the monitor during monitoring of a (b)(6) newborn infant.There was no problem with the measurement and the correct value which was about 60mmhg was shown on the nihon koden patient monitor.However, on the 4th day of use, a value around 20mmhg was shown while the expected value should've been around 60mmhg.The device was exchanged and the correct value of 60mmhg was observed.There were no error messages observed on the monitor.The patient was not treated based on the incorrect value.

• Brand Name: CUSTOM DEFINED PRODUCT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5496198
• MDR Text Key: 40647241
• Report Number: 2015691-2016-00766
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL2601TS_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1