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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC

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MEDOS INTERNATIONAL SàRL FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284002
Device Problem Increase in Pressure (1491)
Patient Problem Not Applicable (3189)
Event Date 01/13/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Device was used for treatment, not diagnosis. Udi: (b)(4).
 
Event Description
It was reported by the sales rep via phone that during a shoulder repair procedure, the fms vue pump was surging and the picture was not clear. The procedure was complete with another pump with no patient harm but there was a ten minute surgical delay to the case to swap out the pump. The sales rep was not present for the case therefore could not provide any further information. The device will be returning for evaluation.
 
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Brand NameFMS VUE PUMP
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key9623524
MDR Text Key206747514
Report Number1221934-2020-00285
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284002
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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