Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 06/08/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
 
Event Description
As reported by the sales rep via phone, the pump outflow suction would not work.They completed case with no delay or patient consequence using the same unit.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the device was received and evaluated at the service center.The reported complaint that the pump outflow suction would not work, was unable to be confirmed.No faults were found with the device upon evaluation.The device was tested and found to be working according to specifications.Since the reported condition is not confirmed,the root cause for the reported failure cannot be determined.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 2/3/2020 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FMS VUE PUMP
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10197616
MDR Text Key202702486
Report Number1221934-2020-01648
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020591
UDI-Public10886705020591
Combination Product (y/n)N
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number284002
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Date Manufacturer Received07/27/2020
Patient Sequence Number1
-
-