MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPY PUMP AND SCALE

Model Number AQL-100CS

Device Problem Defective Device (2588)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

The scale aql-100cs was not sent in for examination.Therefore, a malfunction that could fulfill the reporting criteria cannot be completely ruled out at present.Further attempts will be made to obtain more information about the complaint situation and to retrieve the units from the complainant.A follow-up report will be submitted.

Event Description

We have been informed of the following event: "territory manager, reports that they had an aquilex system that was giving a negative deficit during a case.The system started properly with a deficit of 100, then it began to decline to -295.Actual deficit was roughly 500 with a manual count.(b)(6) reports that the bladder was not emptied in the underbuttocks or primed, as there was no reason for this.Rep was present.No patient impact reported.".

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: HYSTEROSCOPY PUMP AND SCALE
• 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: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 12962838
• MDR Text Key: 283485352
• Report Number: 3002914049-2021-00007
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112642
• 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: 12/01/2021

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-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1