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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, PRODUCT CODE
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W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPIC INSUFFLATOR, PRODUCT CODE Back to Search Results
Model Number AQL-100CBS
Device Problems Incorrect Measurement (1383); Application Program Problem (2880)
Patient Problem Insufficient Information (4580)
Event Date 03/08/2021
Event Type  malfunction  
Manufacturer Narrative
Corresponding scale unit: aql-100pbs, serial number (b)(4).The device was not returned for evaluation yet.The most possible root cause is a defective weighing cell, which might be the result of rough handling of the scale.A follow-up report will be submitted when new information is available.
 
Event Description
We have been informed of the following event: "technical support was contacted by (b)(6), territory manager, to report holx owned aquilex system "aquilex is not calculating the deficit correctly.It bounces around and runs negative.Three cases were completed today but all had to be manually counted.No issues with the patients.Date of case was (b)(6) 2021."".
 
Manufacturer Narrative
The results of the investigation performed indicated that the returned device is working according to specification.The device is in poor condition and the preventive maintenance is overdue.The most possible root cause is an uncalibrated weighing cell, as the result of rough handling of the scale and missed preventive maintenance.
 
Event Description
We have been informed of the following event: "technical support was contacted by (b)(6), territory manager, to report holx owned aquilex system "aquilex is not calculating the deficit correctly.It bounces around and runs negative.Three cases were completed today but all had to be manually counted.No issues with the patients.Date of case was (b)(6) 2021".
 
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Brand Name
AQUILEX FLUID CONTROL SYSTEM
Type of Device
HYSTEROSCOPIC INSUFFLATOR, PRODUCT CODE
Manufacturer (Section D)
W.O.M. WORLD OF MEDICINE GMBH
salzufer 8
berlin, 10587
GM  10587
MDR Report Key11618235
MDR Text Key266973901
Report Number3002914049-2021-00005
Device Sequence Number1
Product Code HIG
UDI-Device Identifier04056702006556
UDI-Public04056702006556
Combination Product (y/n)N
PMA/PMN Number
K172040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/05/2021
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-100CBS
Device Catalogue NumberAQL-100CBS
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/11/2021
Initial Date FDA Received04/06/2021
Supplement Dates Manufacturer Received03/11/2021
Supplement Dates FDA Received07/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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