MAUDE Adverse Event Report: CONVATEC INC. ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE

Model Number ABV301

Device Problem Calibration Problem (2890)

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

Event Date 01/30/2015

Event Type  malfunction  

Event Description

A nurse reported that the device was placed in the pt on (b)(6) 2015 and after many tries, it was noted that the device was not working correctly as it presented both negative values and high values in the same time.The nurse further reported that the device was removed on the same day.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.

• Brand Name: ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE
• Manufacturer (Section D): CONVATEC INC.; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, interim assoc ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4579988
• MDR Text Key: 18071790
• Report Number: 1049092-2015-00129
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABV301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2015
• 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