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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS XD DUAL FLAT SCREEN HOLDER HOLDER, CAMERA, SURGICAL

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MAQUET SAS XD DUAL FLAT SCREEN HOLDER HOLDER, CAMERA, SURGICAL Back to Search Results
Model Number ARD567701940
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2020 getinge became aware of an issue with xd dual flat screen holder. As it was stated, four screws that hold the handle have been snapped off. There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
 
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Brand NameXD DUAL FLAT SCREEN HOLDER
Type of DeviceHOLDER, CAMERA, SURGICAL
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 Key11001722
MDR Text Key221279001
Report Number9710055-2020-00507
Device Sequence Number1
Product Code FXR
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD567701940
Device Catalogue NumberARD567701940
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/03/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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