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-100CBS
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/16/2018
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 were notified of the following event: "deficit problems - (b)(6) contacted technical support regarding customer owned aquilex pump serial number (b)(4) the tm reported that the aquilex system is having deficit issues and needs to be replaced.Pump is on case# (b)(4) the cart & scale is on case # (b)(4) shipping to attn: (b)(6) note 1:potential patient impact? no harm reported has service orders? true".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AQUILEX FLUID CONTROL SYSTEM
Common Device Name
HYSTEROSCOPY PUMP AND SCALE
Manufacturer (Section D)
W.O.M. WORLD OF MEDICINE GMBH
salzufer 8
berlin, 10587
GM  10587
MDR Report Key8690344
Report Number3002914049-2019-00004
Device Sequence Number16785901
Product Code HIG
UDI-Device Identifier04056702006556
UDI-Public04056702006556
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K172040
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Repair
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 NumberAQL-100CBS
Device Catalogue NumberAQL-100CBS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/16/2018
Initial Report FDA Received Date06/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-