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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS MODULE MOBILI 800 MODUTEC; TUBING, PRESSURE AND ACCESSORIES
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MAQUET SAS MODULE MOBILI 800 MODUTEC; TUBING, PRESSURE AND ACCESSORIES Back to Search Results
Model Number ARD517001956
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
 
Event Description
On 9th november, 2023 getinge became aware of an issue with one of surgical equipment - module mobili 800 modutec.It was found during annual preventive maintenance the rubber is torn.Based on photographic evidence the rubber was split.It was stated this is a user damage.There was no injury reported, however, we decided to report the issue in abundance of caution as any part or particles falling off into sterile field or during procedure may cause contamination if the situation was to reoccur.
 
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Brand Name
MODULE MOBILI 800 MODUTEC
Type of Device
TUBING, PRESSURE AND ACCESSORIES
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
MDR Report Key18179817
MDR Text Key328623573
Report Number9710055-2023-00896
Device Sequence Number1
Product Code BYX
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD517001956
Device Catalogue NumberARD517001956
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/09/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/26/2008
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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