MAUDE Adverse Event Report: CONVATEC INC. ABVISER-INTRA ABD PRESSURE MONITOR DEVICE; DEVICE, VYSTOMETRIC, HYDRAULIC

Model Number ABV301

Device Problems Display Difficult to Read (1181); Device Difficult to Program or Calibrate (1496)

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

Event Date 05/13/2014

Event Type  malfunction  

Event Description

It is reported that during use of the device complainant reports previously getting a waveform pattern adn then not getting an accurate waveform pattern.Education was provided on how to zero out the transducer and also the suggestion of replacing it.Complainant verified transducer mounted at mid axillary.Lastly, there were no reports of untoward effect to patient.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction complainant verified no lot number available.No additional patient/event detail have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.

• Brand Name: ABVISER-INTRA ABD PRESSURE MONITOR DEVICE
• Type of Device: DEVICE, VYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3921509
• MDR Text Key: 4519447
• Report Number: 1049092-2014-00182
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABV301
• Device Catalogue Number: ABV301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2014
• 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