MAUDE Adverse Event Report: WOLFE TORY MEDICAL 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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

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 ns it did not allow a reading to be done.Several attempts were made.The unit was discontinued and the nurse obtained an iap reading without abviser.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): WOLFE TORY MEDICAL INC; 79 west 4500 south suite 18; salt lake city UT 84107
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5208155
• MDR Text Key: 30645390
• Report Number: 1722554-2015-31300
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: ABV321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• 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