MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620050200

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/19/2018

Event Type  malfunction  

Event Description

Code on machine said "invalid tubing".

• Brand Name: PNEUMOCLEAR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; 4531 36th st.; orlando FL 32811
• MDR Report Key: 9219077
• MDR Text Key: 163182633
• Report Number: 9219077
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2019

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: No Information
• Device Catalogue Number: 0620050200
• Device Lot Number: 4012759
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1