Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPY PUMP AND SCALE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPY PUMP AND SCALE Back to Search Results
Model Number AQL-100CS
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Affected devices: aquilex fluid control system consisting of.Pump: aql-100p: 1601ce0401.Scale: aql-100cs: 1304ce415.A malfunction cannot be ruled out, because the complaint description states that tests have been performed by the territory manager and these tests failed.It remains unknown which tests have been performed and whether the deficit issues are serious enough to lead to a serious injury.Patient harm has not been reported.A follow-up report will be submitted after the device has been tested.
 
Event Description
We have been informed of the following event: "technical support was contacted by (b)(6) territory manager, to report customer owned aquilex system is having deficit issues.(b)(6) performed the testing and it failed.".
 
Manufacturer Narrative
Affected devices: aquilex fluid control system consisting of pump: aql-100p: (b)(6); scale: aql-100cs: (b)(6).The inital report was filed with fda on 13th december 2019 (mfr# 3002914049-2019-00018).At that time a malfunction could not be ruled out, because the complaint description states that tests have been performed by the territory manager and these tests failed.It still remains unknown which tests have been performed and whether the deficit issues have been serious enough to lead to a serious injury.Patient harm has not been reported.The complainant only returned the pump aql-100p, which was found to be working according to specifications.Until today, the scale aql-100cs has not been returned to the manufacturer.Therefore the case is closed.
 
Event Description
We have been informed of the following event: "technical support was contacted by (b)(6) territory manager, to report customer owned aquilex system is having deficit issues.(b)(6) performed the testing and it failed.".
 
Manufacturer Narrative
Affected devices: aquilex fluid control system consisting of pump: aql-100p: 1601ce0401.Scale: aql-100cs: 1304ce415.The inital report was filed with fda on 13th december 2019 (mfr# 3002914049-2019-00018) and a first follow up report was filed with fda on 11th may 2020.Patient harm has not been reported.In the meantime we have been informed that the scale aql-100cs was returned and evaluated.The returned device shows several signs of forceful manipulation, which most likely caused mechanical and/ or electronic damages, leading to decalibration and thus to problems during deficit determination.The device also displayed an error with the scale connection.The scale was calibrated, deficit tests were repeated and passed.No further errors occurred.
 
Event Description
We have been informed of the following event: "technical support was contacted by eric koller territory manager, to report customer owned aquilex system is having deficit issues.Eric performed the testing and it failed.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9465315
MDR Text Key219793416
Report Number3002914049-2019-00018
Device Sequence Number1
Product Code HIG
UDI-Device Identifier04056702002145
UDI-Public04056702002145
Combination Product (y/n)N
PMA/PMN Number
K112642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup,Followup
Report Date 05/25/2020
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 NumberAQL-100CS
Device Catalogue NumberAQL-100CS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2020
Initial Date Manufacturer Received 11/13/2019
Initial Date FDA Received12/13/2019
Supplement Dates Manufacturer Received11/13/2019
11/13/2019
Supplement Dates FDA Received05/11/2020
05/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-