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

Model Number AQL-100CS

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2021

Event Type  malfunction  

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 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
• Type of Device: AQL-100CS
• 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: michael steinhauser ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 12030850
• MDR Text Key: 260303372
• Report Number: 3002914049-2021-00006
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: AQL-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1