MAUDE Adverse Event Report: CONVATEC INC. ABVISER AUTOVALVE IAP MONITORING DEVICE WITH EDWARDS TRANSDUCER, POLE MOUNT; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV321

Device Problem Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Initial emdr is being re-submitted per request of fda on 29-apr-2021.Reported to the fda on 06-nov-2015.On 17-dec-2015, the following correction was identified: the report submitted on 06-nov-2015, with the patient identifier (b)(6), had the incorrect manufacturer report number listed 1722554-2015-31300.The correct manufacturers report number should have been 1049092--2015-31300.In addition, fields has been updated to reflect this correction.Reported to the fda on 18-dec-2015.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

It was reported that the nurse could not zero out the transducer.The unit seemed to be working fine but once she instilled the normal saline, it did not allow a reading to be done.Several attempts were made.The unit was discontinued and the nurse obtained an intra-abdominal pressure reading without adviser.A new unit was not used and there were no ill effects to the patient.

• Brand Name: ABVISER AUTOVALVE IAP MONITORING DEVICE WITH EDWARDS TRANSDUCER, POLE MOUNT
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 5309726
• MDR Text Key: 266967836
• Report Number: 1049092-2015-31300
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2014

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
• Device Operator: Health Professional
• Device Model Number: ABV321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 12/18/2015
• 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: Unknown
• Patient Sequence Number: 1