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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to a revision in company procedures after a recent internal audit, this historical event was determined to be reportable.
Event or Problem 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
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 8690337
• Report Number: 3002914049-2019-00006
• Device Sequence Number: 2663293
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1