MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM AQL-100S; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM

Model Number AQL-100CBS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

Due to a revision in company procedures after a recent internal audit, this historical event was determined to be reportable.

Event Description

We have been informed of the following event: "technical support was contacted by (b)(6), territory manager, to report the customers new aquilex system was giving negative inaccurate fluid deficits today.Tech support advised to check to make sure there was no pink packing tubes on the scale.To check to make sure the wheels are on ok, that the bag deflector and other pieces do not look damaged.Tech support recommended running the testing in the operators manual.(b)(6) will go on site later this week to run the tests.Pump serial (b)(4) reported in case (b)(4).Cart serial (b)(4) reported in case (b)(4)".

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL-100S
• Type of Device: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: sören markworth ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 8690337
• MDR Text Key: 148305618
• Report Number: 3002914049-2019-00006
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/11/2019

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: Health Professional
• Device Model Number: AQL-100CBS
• Device Catalogue Number: AQL-100CBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1