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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284002
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6). (b)(4).
 
Event Description
It was reported by the affiliate via phone that during an unknown procedure the fms vue pump had a failure on the suction mode. No patient consequence and no surgical delay was reported. No additional information was provided.
 
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Brand NameFMS VUE PUMP
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9850240
MDR Text Key201719499
Report Number1221934-2020-00905
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
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 Manufacturer09/04/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
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
Removal/Correction NumberN/A

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