MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH HYSTEROSCOPY PUMP AND SCALE; AQL-100CS

Model Number	AQL-100CS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The most probable root cause was either (1) a damaged or a de-calibrated weighing cell, (2) objects placed on the containers or (3) fluid on the under-buttocks-drape remaining and afterwards the deficit was zeroed out on the device.Affected devices: pump serial (b)(4).Cart serial (b)(4).
Event or Problem Description
Technical support was contacted by (b)(6), territory manager, to report customer owned aquilex system is showing a negative deficit and is due for a pm.

• Brand Name: HYSTEROSCOPY PUMP AND SCALE
• Common Device Name: AQL-100CS
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ,; GM 10587,
• MDR Report Key: 12030850
• Report Number: 3002914049-2021-00006
• Device Sequence Number: 3592195
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: AQL-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1