MAUDE Adverse Event Report: COVATEC INC ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVI; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV320

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

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

Event Date 12/04/2013

Event Type  malfunction  

Event Description

The following complaint was reported: a nurse who was recording urine output noticed there was no urine in foley bag upon assessment.Urine began flowing again as soon as abviser was discontinued.

Manufacturer Narrative

Based on the info provided this event is deemed a reportable malfunction.Complaint states new abviser was not placed as end user was stabilizing at that time.No additional pt/event details have been provided to date.A return sample for evaluation is not expected.Should additional info become available a follow-up report will be submitted.Reported to the fda on (b)(6) 2014.Note: the actual date of event is unk, so the date used was the date convatec became aware.

• Brand Name: ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVI
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): COVATEC INC; 200 headquarters park dr.; skillman NJ 08558
• Manufacturer Contact: mary szaro, associate dir ; 200 headquarters park dr.; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3697329
• MDR Text Key: 4250299
• Report Number: 2243969-2014-00003
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABV320
• Device Catalogue Number: ABV320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2013
• 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: Unknown
• Patient Sequence Number: 1