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 Component (2292)

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

Event Type  malfunction  

Event Description

We have been informed of the following event: "technical support was contacted by (b)(6) territory manager, to report hologic owned aquilex system is "the below aquilex pump/scale continue to show a negative deficit.There has been no reported adverse events, account has just been using pump and manually calculating the deficit." pump serial (b)(4) reported in (b)(4).Cart serial (b)(4) reported in (b)(4).Contact is (b)(6).Sr note 1: potential patient impact? no harm reported.".

Event Description

We have been informed of the following event: " technical support was contacted by rhonda myers territory manager, to report hologic owned aquilex system is "the below aquilex pump/scale continue to show a negative deficit.There has been no reported adverse events, account has just been using pump and man-ually calculating the deficit." pump serial (b)(6) reported in case (b)(4) tracking (b)(4) cart serial (b)(6) reported in case (b)(4) tracking (b)(4) contact is (b)(6).Sr note 1: potential patient impact? no harm reported".

Manufacturer Narrative

The event was initially reported to fda on (b)(6)2019 (mfr# (b)(4)).Until today, neither the device nor further information could be obtained from the complainant.The case was closed.

• 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
• MDR Report Key: 9178330
• MDR Text Key: 217200217
• Report Number: 3002914049-2019-00014
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (y/n): N
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

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-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1