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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM
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W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM Back to Search Results
Model Number AQL-100CS
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2019
Event Type  malfunction  
Event Description
We have been informed of the following event: "tm contacted technical support on: 07/10/2019 regarding customer owned aquilex pump serial number (b)(4) and cart & scale serial (b)(4).The customer reported that the pump is not calculating deficit correctly.The rep would like to have this replaced along with the aquilex pump.".
 
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Brand Name
AQUILEX FLUID CONTROL SYSTEM
Type of Device
HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM
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
soeren markworth
salzufer 8
berlin, 10587
GM   10587
MDR Report Key8877768
MDR Text Key162118117
Report Number3002914049-2019-00009
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
Reporter Occupation Other
Type of Report Initial
Report Date 08/09/2019
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 NumberAQL-100CS
Device Catalogue NumberAQL-100CS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2019
Initial Date Manufacturer Received 07/11/2019
Initial Date FDA Received08/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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